Systems and methods for performing minimally invasive procedures

ABSTRACT

A robotic medical surgical system configured for performing prostate procedures includes a controller including a master input device, an instrument driver in communication with the controller, an instrument assembly operatively coupled to the instrument driver, and a surgical tool operatively coupled to the controller and carried on the distal end portion of the instrument assembly, wherein the controller and master input device are configured to allow a system operator to position the surgical tool proximate a prostate abnormality without entering a restricted zone, at least partially automatically controlled based on an images obtained of the surgical zone.

RELATED APPLICATION DATA

The present application is a continuation of U.S. application Ser. No.11/833,969, filed on Aug. 3, 2007, which claims the benefit under 35U.S.C. §119 to U.S. Provisional Patent Application Ser. Nos. 60/835,592,filed on Aug. 3, 2006; 60/838,075, filed on Aug. 15, 2006; and60/840,331, filed on Aug. 24, 2006. The foregoing applications, alongwith U.S. patent application Ser. No. 11/829,076, filed Jul. 26, 2007,are all incorporated by reference into the present application in theirentirety for all purposes.

FIELD OF INVENTION

The invention relates generally to robotically controlled systems, suchas telerobotic surgical systems, and more particularly to roboticcatheter systems for performing minimally invasive diagnostic andtherapeutic procedures.

BACKGROUND

Robotic diagnostic and interventional systems and devices are wellsuited for use in performing minimally invasive medical procedures, asopposed to conventional techniques wherein a patient's body cavity isopen to permit the surgeon's hands access to the internal organs. Thereis a need for highly controllable yet minimally sized systems tofacilitate imaging, diagnosis, and treatment of tissues which may liedeeply and/or concealed within the body cavity of a patient, and whichmay be accessed through natural body orifices or percutaneous incisionsand by way of naturally-occurring pathways such as blood vessels orother bodily lumens.

SUMMARY OF THE INVENTION

In accordance with one aspect of the disclosed inventions, a roboticsurgical system includes an instrument driver, an instrument assemblyoperatively coupled to the instrument driver such that mechanisms of theinstrument driver operate or control movement, operation, or both, ofcomponents of the instrument assembly, and an operator control stationoperatively coupled to the instrument driver via a remote communicationlink. The instrument assembly components include an elongate flexibleguide instrument, an optical light source, a camera and a working tool,wherein the light source, camera, and working tool are carried in one ormore lumens of the guide instrument. The instrument assembly furtherincludes an inflatable visualization balloon carried on a distal endportion of the guide instrument, the light source and camera havingdistal ends located within an interior of the balloon, the ballooncomprising a lumen extending from the guide instrument to a distalfacing wall of the balloon, wherein the working instrument may extendfrom a respective lumen of the guide instrument through the balloonlumen to contact body tissue when the distal end of the guide instrumentis positioned in an interior body region. In one embodiment, the workinginstrument is a laser fiber, e.g., a lithotripsy laser fiber such as aHolmium YAG laser, which may be movable relative to the guideinstrument. In other embodiments, the working instrument may be a tissuegrasper or manipulator, or a basket apparatus, which may be movablerelative to the guide instrument. In some embodiments, the instrumentassembly components further include a sheath instrument, wherein theguide instrument is carried in a lumen of, and is movable relative to,the sheath instrument.

In accordance with another aspect of the disclosed inventions, a roboticsurgical system includes an instrument driver, an instrument assemblyoperatively coupled to the instrument driver such that mechanisms of theinstrument driver operate or control movement, operation, or both, ofcomponents of the instrument assembly, and an operator control stationoperatively coupled to the instrument driver via a remote communicationlink. The instrument assembly components include an elongate guideinstrument sized for being positioned in a urethra, an image capturedevice and a working tool, wherein the image capture device and workingtool are carried in one or more lumens of the guide instrument, whereinmovement, operation, or both, of components of the instrument assemblyare at least partially automatically controlled based on images obtainedby the image capture device. In one embodiment, the working instrumentis a laser fiber, e.g., a lithotripsy laser fiber such as a Holmium YAGlaser, which may be movable relative to the guide instrument. In someembodiments, the image capture device is an imaging fiber. In someembodiments, a flush port is provided in fluid communication with afluid flush lumen extending through the guide instrument. By way ofnon-limiting example, the fluid flush lumen may be provided in a tubularbody that extends out of a distal end of the guide instrument. In somesuch embodiments, the tubular body has a distal end section that bendsor curves back in a proximal facing direction, such that fluiddischarged out of the flush port is directed at the distal end of theguide instrument. In some embodiments, the imaging device is carried inthe tubular body. In some embodiments, the instrument assemblycomponents further include a sheath instrument, wherein the guideinstrument is carried in a lumen of, and is movable relative to, thesheath instrument. In some embodiments, a second working instrument(e.g., a wire loop apparatus or tissue grasper) may be carried in alumen of the guide instrument.

In accordance with yet another aspect of the disclosed inventions, arobotic surgical system includes an instrument driver, an instrumentassembly operatively coupled to the instrument driver such thatmechanisms of the instrument driver operate or control movement,operation, or both, of components of the instrument assembly. Theinstrument assembly components include an elongate sheath instrumentsized for positioning in a urethra, an elongate guide instrument carriedin a lumen of and movable relative to the sheath instrument, and aresectoscope carried in a lumen of the guide instrument.

Other aspects and advantages of the present invention will becomeapparent from the following description, taken in conjunction with theaccompanying drawings, illustrating by way of examples the principles ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be readily understood by the followingdetailed description, taken in conjunction with accompanying drawings,illustrating by way of examples the principles of the invention. Thedrawings illustrate the design and utility of preferred embodiments ofthe present invention, in which like elements are referred to by likereference symbols or numerals. The objects and elements in the drawingsare not necessarily drawn to scale, proportion, or precise positionalrelationships; instead emphasis is focused on illustrating theprinciples of the invention.

FIG. 1 illustrates one embodiment of a robotic surgical system.

FIG. 2 illustrates another embodiment of a robotic surgical system.

FIG. 3 illustrates one embodiment of a robotic surgical system beingused to perform diagnostic and/or interventional operations on apatient.

FIG. 4A illustrates a cross sectional view of a heart.

FIG. 4B illustrates an instrument assembly advanced into a chamber ofthe heart.

FIG. 4C illustrates an ablation tool advanced through the lumen of theinstrument assembly into a chamber of the heart.

FIG. 5A illustrates a target of an operation site in a chamber of theheart.

FIG. 5B illustrates an instrument assembly advanced toward a target sitein a chamber of the heart.

FIG. 5C illustrates an ablation tool advanced through a lumen of aninstrument assembly toward a target site in a chamber of the heart.

FIG. 6A through 6C respectively illustrate an instrument assembly and anablation tool being used to address a target site related toatrioventricular nodal reentrant tachycardia.

FIG. 7A through FIG. 7C respectively illustrates an instrument assemblyand an ablation tool being used to address a target site related toventricular tachycardia.

FIG. 7D through FIG. 7F respectively illustrates an instrument assemblybeing used to address a target site related to a left-sided ventriculartachycardia.

FIG. 7G through FIG. 7I respectively illustrates a retrograde approachto address a ventricular tachycardia condition.

FIG. 8A illustrates an instrument assembly being used to treat a patentforamen ovale condition.

FIG. 8B illustrates an instrument assembly with an ablation tool beingused to treat a patent foramen ovale condition.

FIG. 8C and FIG. 8D respectively illustrates an instrument assembly witha suturing tool being used to treat a patent foramen ovale condition.

FIG. 8E and FIG. 8F respectively illustrates an instrument assembly witha clip application tool being used to treat a patent foramen ovalecondition.

FIG. 8G and FIG. 8H respectively illustrates an instrument assembly witha needle instrument being used to treat a patent foramen ovalecondition.

FIG. 8I and FIG. 8J respectively illustrates an instrument assembly withan irritation tool being used to treat a patent foramen ovale condition.

FIG. 9A and FIG. 9B respectively illustrates an instrument assembly witha suturing tool being used to treat a left atrial appendage occlusioncondition.

FIG. 9C through FIG. 9H respectively illustrates an instrument assemblycoupled with various tools being used to treat a left atrial appendageocclusion condition.

FIG. 10A and FIG. 10B respectively illustrates an instrument assemblywith lead deploying tool.

FIG. 10C and FIG. 10D respectively illustrates an instrument assemblydeploying leads in the right and left atrium of the heart.

FIG. 11A through FIG. 11F respectively illustrates an instrumentassembly with various tools being used to treat a chronic totalocclusion condition.

FIG. 12A and FIG. 12B respectively illustrates an instrument assemblywith an injection tool being used to treat congestive heart failurecondition.

FIG. 12C illustrates one embodiment of an injection pattern for treatinginfarcted tissue.

FIG. 13A through FIG. 13G respectively illustrates an instrumentassembly with various tools being used to perform valve repairprocedures.

FIG. 13H and FIG. 13I illustrate the chords, chordae tendineae, orpapillary muscle of the mitral valve leaflet being adjusted.

FIG. 14 illustrates an instrument assembly with an ablation tool beingused to perform valve repair.

FIG. 15A through FIG. 15D illustrate a retrograde method to deploy anexpandable aortic valve prosthetic to repair an aortic valve.

FIG. 15E through FIG. 15J illustrate a method of deploying an expandablevalve prosthetic by way of the inferior vena cava through the septum andthe mitral valve to the aortic valve.

FIG. 15K illustrates a two-handed approach to deploy an expandable valveprosthetic.

FIG. 16 illustrates an instrument assembly with a lithotripsy laserfiber for performing lithotripsy procedures.

FIG. 17 illustrates an instrument assembly with a grasper including anenergy source configured for performing lithotripsy procedures.

FIG. 18 illustrates an instrument assembly with a basket tool includingan energy source configured for performing lithotripsy procedures.

FIG. 19 illustrates an expandable grasping tool assembly including anenergy source.

FIG. 20 illustrates a bipolar electrode grasper assembly.

FIG. 21 illustrates an instrument assembly configured with basket arms.

FIG. 22 illustrates an instrument assembly including a lithotripsy fiberand image capture device.

FIG. 23 illustrates an instrument assembly including a grasping tool.

FIG. 24 illustrates an instrument assembly including a basket toolapparatus.

FIG. 25 and FIG. 26 respectively illustrates an operation of aninstrument assembly with a basket tool apparatus.

FIG. 27 illustrates an instrument assembly including a basket armcapture device and image capture device.

FIG. 28 illustrates an instrument assembly including a balloonapparatus.

FIG. 29 illustrates an instrument assembly including another balloonapparatus.

FIG. 30 illustrates an instrument assembly including yet another balloonapparatus.

FIG. 31 through FIG. 33 respectively illustrates an instrument assemblyincluding an inflatable balloon cuff apparatus.

FIG. 34 through FIG. 36 respectively illustrate an instrument assemblyincluding a flexible balloon cuff apparatus.

FIG. 37 and FIG. 38 respectively illustrates an instrument assemblyincluding image capture apparatuses.

FIG. 39 through FIG. 40 respectively illustrates detailed views of theimage capture assembly.

FIG. 41 illustrates a cross sectional view of a tubular structure forhousing the image capture device assembly.

FIG. 42 through FIG. 45 respectively illustrates variations ofembodiments of image capture assembly.

FIG. 46A illustrates a steerable instrument assembly being used in thebladder.

FIG. 46B illustrates a steerable instrument assembly being used in theprostate.

FIG. 47 illustrates another steerable instrument assembly.

FIG. 48 and FIG. 49 respectively illustrates yet another steerableinstrument assembly.

FIG. 50A illustrates one embodiment of a sheath and catheter assemblytogether with a retracted conical balloon apparatus.

FIG. 50B illustrates the embodiment of FIG. 50A wherein the retractedconical balloon apparatus is deployed.

FIG. 51 illustrates one embodiment of a sheath and catheter assemblywith a deflated balloon apparatus.

FIG. 52 illustrates a sheath and catheter assembly with one embodimentof an inflated balloon apparatus.

FIG. 53 illustrates a sheath and catheter assembly with one embodimentof a toroid shaped balloon.

FIG. 54 illustrates a sheath and catheter assembly with distal tipportion of the catheter where a balloon apparatus may be deployed ishighlighted.

FIG. 55 illustrates one embodiment of a conical shaped balloon apparatusmanufactured with a heat bonding process.

FIG. 56 illustrates another embodiment of a conical shaped balloonapparatus.

FIG. 57 illustrates one embodiment of a cylindrical shaped balloonapparatus manufactured with a heat bonding process.

FIG. 58 illustrates one embodiment of a conical shaped balloon apparatushaving two chambers that can be inflated to different pressures.

FIG. 59 illustrates one embodiment of a conical shaped balloon apparatushaving one inflatable chamber and a soft distal tip.

FIG. 60 illustrates one embodiment of a conical shaped balloon apparatushaving structural reinforcement wires.

FIG. 61 illustrates one embodiment of a cup shaped balloon apparatushaving a stent type or mesh type of reinforcement.

FIG. 62 illustrates one embodiment of a cylindrical shaped balloonapparatus having a stent type or mesh type of reinforcement.

FIG. 63 illustrates one embodiment of a cup shaped balloon apparatushaving lateral ring supports.

FIG. 64 illustrates one embodiment of a cup-shaped balloon apparatushaving a first chamber with a stent or type of reinforcement structureand a distal second chamber without the stent or mesh typereinforcement.

FIG. 65 illustrates one embodiment of a cup shaped balloon apparatushaving a first chamber with a stent or mesh type of reinforcementstructure and a distal edge portion constructed of a soft material.

FIG. 66 illustrates one embodiment of a cup-shaped balloon apparatuswith an image capture device and flush port at the distal portion of acatheter.

FIG. 67 illustrates one embodiment of a catheter having a cup-shapedballoon apparatus with an image capture device, a flush port, and aworking lumen at the distal portion of a catheter.

FIG. 68 illustrates one embodiment of a toroid-shaped balloon apparatuswith a suction port at the distal portion of a catheter.

FIG. 69 illustrates one embodiment of a balloon apparatus with supportribs.

FIG. 70 illustrates one embodiment of two-layered balloon apparatus withan image capture device at the distal portion of a catheter.

FIG. 71 illustrates one embodiment of a side-firing ultrasoundtransducer enclosed within an inflated balloon apparatus at the distalportion of a catheter.

FIG. 72 illustrates one embodiment of a balloon apparatus with spikes atthe distal portion of a catheter.

FIG. 73 illustrates one embodiment of a balloon apparatus with spines atthe distal portion of a catheter.

FIG. 74 illustrates one embodiment of an image capture device with areticle and illumination fibers enclosed within a balloon apparatus atthe distal portion of a catheter.

FIG. 75 illustrates one embodiment of an articulating endoscope enclosedwithin a balloon apparatus at the distal portion of a catheter.

FIG. 76 illustrates one embodiment of a laser fiber and an image capturedevice enclosed within a balloon apparatus at the distal portion of acatheter.

FIG. 77 illustrates one embodiment of an image capture device andillumination fibers enclosed within a balloon apparatus havingmagnifying lenses at the distal portion of a catheter.

FIG. 78 illustrates one embodiment of a balloon apparatus having a radiofrequency (RF) electrode deployed on its surface.

FIG. 79 illustrates one embodiment of a balloon apparatus having amagnet on its outer surface.

FIG. 80 illustrates one embodiment of balloon apparatus having a pair ofmapping electrodes mounted on its outer surface.

FIG. 81 illustrates one embodiment of a balloon apparatus having athrough lumen.

FIG. 82 illustrates one embodiment of a balloon apparatus having anablation tool deployed in its through lumen.

FIG. 83 illustrates one embodiment of a balloon apparatus having agrasper deployed in its through lumen.

FIG. 84 illustrates one embodiment of a balloon apparatus having abasket tool deployed in its through lumen.

FIG. 85 illustrates a balloon apparatus and an ablation catheterdeployed in a working lumen located outside of the balloon apparatus ata distal portion of a catheter.

FIG. 86 illustrates a balloon apparatus and a grasper deployed in aworking lumen located outside of the balloon apparatus at the distalportion of a catheter.

FIG. 87 illustrates a balloon apparatus and a basket tool apparatusdeployed in a working lumen located outside of the balloon at the distalportion of a catheter.

FIG. 88 through FIG. 90 respectively illustrates various views of oneembodiment of a mold for manufacturing a balloon apparatus.

FIG. 91 through FIG. 95 respectively illustrates one embodiment of amethod for deploying an angioplasty ring with a balloon apparatus.

FIG. 96 illustrates one method for performing ablation using a balloonapparatus.

FIG. 97 illustrates one embodiment of a toroid-shaped balloon apparatusthat is deployed and an ablation tool.

FIG. 98 illustrates one embodiment of a circular-shaped balloonapparatus with an electrode strip mounted on its outer surface.

FIG. 99 illustrates one a method of performing electro-anatomic mappingand RF ablation with a balloon apparatus using electrodes.

FIG. 100 illustrates the top surface of a balloon apparatus of FIG. 99.

FIG. 101 through 104 respectively illustrates one method for performingpatent foramen ovale procedure using a balloon apparatus.

FIG. 105 illustrates one embodiment of a method for aortic valvedestenosis/decalcification using a balloon apparatus.

FIG. 106 illustrates a prostate with benign prostatic hyperplasia.

FIG. 107 illustrates a steerable sheath and guide catheter traveling upa urethra.

FIG. 108 illustrates a close-up view of the prostate with one embodimentof a catheter that includes a laser and imaging fiber.

FIG. 109 illustrates another close-up view of the prostate with oneembodiment of a catheter that includes a laser, imaging fiber, and flushport.

FIG. 110 illustrates yet another close-up view of the prostate withanother embodiment of a catheter that includes a laser, imaging fiber,and flush port.

FIG. 111 illustrates additional close-up view of the prostate with yetanother embodiment of a catheter that includes a laser, imaging fiber,and flush port.

FIG. 112 illustrates a further close-up view of the prostate with stillanother embodiment of a catheter that includes a laser, imaging fiber,and flush port.

FIG. 113 illustrates a yet further close-up view of the prostate withone embodiment of a catheter that includes a laser and grasper.

FIG. 114 illustrates another close-up view of the prostate with oneembodiment of a resectoscope deployed within the working lumen of asteerable guide catheter.

FIG. 115 illustrates yet another close-up view of the prostate with oneembodiment of a catheter that includes a wire loop, imaging fiber, andflush port.

FIG. 116 illustrates one embodiment of a robotic catheter system thatincludes both a master input device and a pair of data gloves.

FIG. 117 illustrates the operator control station of FIG. 116.

FIG. 118 illustrates another embodiment of an operator control stationthat includes a master input device and a pair of data gloves.

FIG. 119 illustrate the input devices of the control station in FIG.118.

FIG. 120 illustrates one embodiment of a robotic catheter system thatincludes data gloves.

FIG. 121 illustrates the operator control station of FIG. 120.

FIG. 122 illustrates another embodiment of an operator control stationincluding a pair of data gloves.

FIG. 123 illustrate the various input devices of a control station.

FIG. 124 illustrates one embodiment of a data glove.

FIG. 125 illustrates one embodiment of a wired data glove

FIG. 126 illustrates one embodiment of a wireless data glove system.

FIG. 127 illustrates a display screen showing sensor data signalsreceived by the system from the data gloves in accordance to oneembodiment.

FIG. 128 illustrates a block diagram of the controls system flow for oneembodiment.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Reference will now be made in detail to the preferred embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with thepreferred embodiments, it will be understood that they are not intendedto limit the invention to these embodiments. On the contrary, theinvention is intended to cover modifications, alternatives, andequivalents that may be included within the spirit and scope of theinvention as defined by the appended claims. Furthermore, in thefollowing detailed description of the embodiments, numerous specificdetails are set forth in order to provide a thorough understanding ofthe present invention. However, it will be readily apparent to oneskilled in the art that the present invention may be practiced withoutthese specific details. In other instances, well-known methods,procedures, and components have not been described in detail so as notto unnecessarily obscure aspects of the present invention.

Standard surgical procedures typically involve using a scalpel to createan opening of sufficient size to enable a surgical team to gain accessto an area in the body of a patient for the surgical team to diagnoseand treat one or more target sites. When possible, minimally invasivesurgical procedures may be used instead of standard surgical proceduresto minimize physical trauma to the patient and reduce recovery time forthe patient to recuperate from the surgical procedures. Minimallyinvasive surgical procedures typically require using extension tools(e.g., catheters, etc.) to approach and address the target site throughnatural pathways (e.g., blood vessels, gastrointestinal tract, etc.)from a remote location either through a natural body orifice or apercutaneous incision. As can be appreciated, the surgeon may havelimited information or feedback (e.g., visual, tactile, etc.) toaccurately navigate the extension tools, such as one or more catheters,and place the working portions of the extension tools at preciselocations to perform the necessary diagnostic and/or interventionalprocedures. Even with such potential limitations, minimally invasivesurgical procedures may be more effective and beneficial for treatingthe patient, instead of standard open surgery.

Minimally invasive diagnostic and interventional operations may requirethe surgeon to remotely approach and address the operation or targetsite by using extension tools. The surgeon usually approaches the targetsite through either a natural body orifice or a small percutaneousincision in the body of the patient. In some situations, the surgeon mayuse multiple extension tools and approach the target site through one ormore natural body orifices as well as small percutaneous incisions inthe body of the patient. Typically, the natural body orifices or smallincisions are located at some distance away from the target site.Extension tools (e.g., various types of catheters and surgicalinstruments) enter the body through one or more natural body orifices orsmall percutaneous incisions, and the extension tools are guided,navigated, manipulated, maneuvered, and advanced toward the target sitetypically by way of natural body pathways (e.g., blood vessels,esophagus, trachea, small intestine, large intestine, urethra, etc.).The extension tools might include one or more catheters as well as othersurgical tools or instruments. The catheters may be manually controlledcatheters or robotically operated catheters. In most situations, thesurgeon has limited visual and tactile information to discern thelocation of the catheters and surgical instruments relative to thetarget site and/or other organs in the patient.

For example, in the treatment of cardiac arrhythmias such as atrialfibrillation (AF), cardiac ablation therapy is applied to the leftatrium of the heart to restore normal heart function. For thisoperation, one or more catheters (e.g., sheath catheter, guide catheter,ablation catheter, endoscopic catheter, intracardiac echocardiographycatheter, etc.) may be inserted through one or more natural orifices orone or more percutaneous incisions at the femoral vein near the thigh orpelvic region of the patient, which is located at some distance awayfrom the operation or target site. In this example, the operation ortarget site for performing cardiac ablation is in the left atrium of theheart. Catheters may be guided (e.g., by a guide wire, a sheath, etc.),manipulated, maneuvered, and advanced toward the target site by way ofthe femoral vein to the inferior vena cava into the right atrium of theheart and through the interatrial septum to the left atrium of theheart. The catheters may be used separately or in combination ofmultiple catheters. Currently, the surgeon has limited visual andtactile information to assist him or her with maneuvering andcontrolling the catheters (separately or in combination). In particular,because of limited information and/or feedback, it is especiallydifficult for the surgeon to maneuver and control one or more distalportions of the catheters to perform cardiac ablation at preciselocations or spots on the surface or wall of the left atrium of theheart. As will be explained below, embodiments of the present inventionprovide improved systems and methods that would facilitate imaging,diagnosis, address, and treatment of tissues which may lie deeply and/orconcealed under other tissues or organs within the body cavity of apatient. With embodiments of the present invention, the surgeon may beable to position the catheter more precisely and accurately to addressthe operation or target sites. For example, with the improved imagingcapability, the surgeon may be able to apply cardiac ablation at thedesired locations or spots on the surface or wall of the left atrium ofthe heart in a more precise and accurate manner to address cardiacarrhythmias such as atrial fibrillation. In addition, U.S. patentapplication Ser. Nos. 11/185,432, filed on Jul. 19, 2005; 11/202,925,filed on Aug. 12, 2005; and 11/481,433, filed Jul. 3, 2006 areincorporated herein by reference in their entirety.

FIG. 1 illustrates one embodiment of a robotic surgical system (100),e.g., the Sensei™ Robotic Catheter System from Hansen Medical, Inc. inMountain View, Calif., U.S.A., an operator control station (102) locatedremotely from an operating table (104) to which an instrument driver(106) and instrument assembly (108), e.g., the Artisan™ Control Catheteralso from Hansen Medical, Inc. in Mountain View, Calif., U.S.A., aresupported by an instrument driver mounting brace (110) that is mountedon the operating table (104). A wired connection (112) transfers signalsbetween an electronics rack (114) at the operator control station (102)and instrument driver (106). The electronics rack (114) includes systemhardware, software, firmware, and combinations thereof thatsubstantially operate and perform the many functions of the roboticsurgical system (100). The instrument driver mounting brace (110) is asubstantially arcuate-shaped structural member configured to positionthe instrument driver (106) above a patient (not shown) who is lying onthe operating table (104). The wired connection (112) may transmitmanipulation and control commands from an operator or surgeon (116) whois working at the operator control station (102) to the instrumentdriver (106) to operate the instrument assembly (108) to performminimally invasive operations on the patient who is lying on theoperating table (104). The surgeon (116) may provide manipulation andcontrol commands using a master input device (MID) (118). In addition,the surgeon may provide inputs, commands, etc. by using one or morekeyboards (120), trackball, mouse, etc. The wired connection (112) mayalso transmit information (e.g., visual views, tactile or forceinformation, position, orientation, shape, localization,electrocardiogram, map, model, etc.) from the instrument assembly (108),the patient, and monitors (not shown in this figure) to the electronicsrack (114) for providing the necessary information or feedback to theoperator or surgeon (116) to facilitate monitoring of the instrumentassembly (108), the patient, and one or more target sites for performingprecise manipulation and control of the instrument (108) during theminimally invasive surgical procedure. The wired connection (112) may bea hard wire connection, such as an electrical wire configured totransmit electrical signals (e.g., digital signals, analog signals,etc.), an optical fiber configured to transmit optical signals, awireless link configured to transmit various types of signals (e.g., RFsignals, microwave signals, etc.), or any combinations of electricalwire, optical fiber, wireless link, etc. The information or feedback maybe displayed on one or more monitors (122) at the operator controlstation (102).

FIG. 2 illustrates another embodiment of a robotic surgical system(100). For more detailed discussions of robotic surgical systems, pleaserefer to U.S. Provisional Patent Application No. 60/644,505, filed onJan. 13, 2005; U.S Patent Application Publication No. 2007-0043338,filed on Jul. 3, 2006; and U.S. patent application Ser. No. 11/637,951,filed on Dec. 11, 2006; and they are incorporated herein by reference intheir entirety.

FIG. 3 illustrates one embodiment of a robotic surgical system (100)configured to perform minimally invasive surgery using one or moreinstrument assemblies (108). For example, the instrument assembly (108)may include a sheath catheter, guide catheter, ablation catheter,endoscopic catheter, intracardiac echocardiography catheter, etc., orany combination thereof. In addition, surgical instruments or tools(e.g., lasers, optics, cutters, needles, graspers, scissors, baskets,balloons, etc.) may be attached or coupled to any one or combination ofthe catheters. In one embodiment, the instrument assembly (108) may be acatheter system that includes a sheath catheter, guide catheter, asurgical catheter, and/or surgical instrument, such as the Artisan™Control Catheter available from Hansen Medical, Inc. at Mountain View,Calif., U.S.A. The instrument assembly (108) also includes all thecontrol mechanisms to operate its various components, e.g., sheathcatheter, guide catheter, a surgical catheter, and/or surgicalinstrument. The robotic surgical system (100) including the controlstation (102), instrument driver (106), instrument (108), and the wiredconnection (112) may be used to treat or perform cardiac relateddiseases, maladies, conditions, or procedures (e.g., atrial flutter,Wolf-Parkinson-White (“WPW”), atrioventricular nodal reentranttachycardia (“AVNRT”), Ventricular tachycardia (“V-tach”), patentforamen ovale (“PFO”), left atrial appendage occlusion, pacing leadplacement, chronic total occlusion (“CTO”), ventricular injectiontherapy, valve repair).

For example, atrial flutter is characterized by a rapid but organizedand predictable pattern of beating of the atria. Similar to atrialfibrillation, the ventricles cannot respond to all of the atrial beats,which may cause blood to accumulate and collect or pool in the atriaincreasing the risk of stroke. FIG. 4A illustrates a cross sectionalview of a heart (400). The cross sectional view illustrates the inferiorvena cava (402), the right atrium (408), the left atrium (410), theright ventricle (412), and left ventricle (414). In addition, FIG. 4Aillustrates a targeted location (416) (e.g., an area for linear lesion)for performing atrial flutter ablation lesion. FIG. 4B illustratesinstrument (108) that may include a robotic sheath instrument orcatheter (422) and a guide instrument or guide catheter (424) that havebeen navigated and positioned through the inferior vena cava (402) intothe right atrium (408). Referring to FIG. 4C, an ablation tool (426) isdepicted as having been navigated and placed through the working lumenof the guide instrument or guide catheter (424) and the ablation tool(426) is depicted as protruding slightly from the distal end of theguide instrument (424) to enable the guide instrument (424) to navigatethe ablation tool (426) or the tip of the ablation tool (426) intoposition against portions of right atrium (408) to create the desiredlesion (e.g., linear lesion), and preferably substantially treat oreliminate atrial flutter.

Wolf-Parkinson-White (“WPW”) is another type of arrhythmia that may becaused by an abnormal bridge of tissue, such as the eustachian ridge,which connects the atria and ventricles of the heart. This accessorypathway allows electrical signals to go back and forth between the atriaand the ventricles without going through the heart's natural pacemaker,or atrioventricular node or AV node. If the signal ricochets back andforth, very fast heart rates and life-threatening arrhythmias candevelop. Referring to FIG. 5A, an example of a targeted location (516)for an ablation lesion near or around the eustachian ridge is depicted.Referring to FIG. 5B, an instrument assembly (108) including a sheathinstrument or sheath catheter (422) and a guide instrument or guidecatheter (424) is depicted with the distal portions of the instruments(422 and 424) positioned in the right atrium (408). Referring to FIG.5C, an ablation tool (526) is advanced through the working lumen orinner channel of the guide instrument (424) to a position wherein it maybe utilized to contact and ablate desired portions of the targetedtissue.

Atrioventricular Nodal Reentrant Tachycardia (“AVNRT”) is a common formof arrhythmia that arises from the atria. There are two distinctpathways between the atria and ventricle, one fast and one slow. InAVNRT, the abnormal signal begins in the atria and transfers to the AVnode. Instead of conducting down to the ventricle, the signal isreturned to the atria. Referring to FIGS. 6A-6C, a sheath (422) andguide (424) instrument assembly (108) may be utilized, along with anablation catheter (626) or ablation electrode (626), to create anablation lesion (616) in the right atrium (408) to address aberrantconduction pathways causing AVNRT.

Ventricular tachycardia (“V-tach”) is a condition arises from the lowerchambers of the heart as the name implies. It is characterized by heartrates over 100 beats per minute, but heart rates often approach 200beats per minute. At this rate, very little blood is actually pumped outof the heart to the brain and other organs. As such, extremely fastV-tach can be fatal. Referring to FIGS. 7A-7C, a sheath (422) and guide(424) instrument assembly (108) may be utilized, along with an ablationcatheter (726) or ablation electrode (726), to create an ablation lesion(716) in, for example, the right ventricle (412), to address aberrantconduction pathways causing right-sided V-tach. To reach the targetedlesion location, the sheath (422) may be positioned adjacent thetricuspid valve (702), and the guide (424) may be navigated across thetricuspid valve (702) to deliver the ablation electrode (726) againstthe targeted tissue, as depicted in FIG. 7C. FIGS. 7D-7F depict asimilar instrument configuration (108) is utilized to address aleft-sided V-tach scenario by navigating across the septum (704), by wayof a transseptal puncture, into the left atrium (410), and down throughthe mitral valve (706) into the left ventricle (414) and to the targetedleft ventricular tissue lesion (736) where an ablation lesion may becreated to prevent aberrant conduction related to V-tach. FIGS. 7G-7Idepict a retrograde approach, through the aorta (404), across the aorticvalve (406), and into the left ventricle (414), subsequent to which thesheath instrument (422) may be utilized to direct the guide instrument(424) and ablation tool (766) up toward the inferior mitral annulusregion (756) where ablation lesions may be created to address a V-tachscenario.

A patent foramen ovale (“PFO”) is an abnormal opening in the arterialseptum which results in shunting of blood between the atrial chambers.PFOs are believed to be present in as many as 20% of the adultpopulation and there is strong evidence that PFOs are responsible forthe occurrence of a type of stroke, known as cryptogenic stroke, whichoccurs as a result of a blood clot in an otherwise healthy individual.Additionally, there is increasing evidence that the presence of a PFO isin some way related to the occurrence of migraine headache with aura incertain patients. Historically, PFOs have been treated with surgery,where the defect is sewn shut with direct suturing. Although this workswell to close the defect, it requires open heart surgery and is verytraumatic, which requires significant post-operative recovery. Morerecently, PFOs have been closed successfully with prosthetic patchesthat are delivered via a catheter based procedure. These proceduresoffer a minimally invasive approach, but require that the clinicianleave prosthesis inside the heart to cover and occlude the PFO defect.The presence of foreign material inside the heart can lead tosignificant complications including infection, thrombus formationleading to stroke, development of cardiac arrhythmias, and dislodgmentor migration of prosthesis that might necessitate surgical removal ofthe devices.

Referring to FIG. 8A, a sheath (422) and guide (424) instrument assembly(108) may be utilized to direct a laser fiber (826) to the location of aPFO (802) and use laser energy to ablate or “weld” the PFO (802) shutwith a concomitant inflammation reaction. Referring to FIG. 8B, anablation tool (836) is threaded through the working lumen of aninstrument assembly (422, 424, 108) may be similarly used to tack a PFO(802) shut and induce a localized healing response. Referring to FIGS.8C and 8D, a suturing tool (846) may be utilized to suture a PFO (802)shut. Referring to FIGS. 8E and 8F, a clip applying tool (856) may beutilized to clip a PFO (802) into a shut position. Referring to FIGS. 8Gand 8H, a needle tool (866) advanced through the working lumen of asheath (422) and guide (424) which are subsystems of the instrumentassembly (108) may be utilized to irritate the tissue surrounding and/orforming the PFO (802), via full or partial thickness insertions of theneedle (866) into the subject tissue, to induce a healing responsesufficient to “scar” the PFO (802) shut. Referring to FIGS. 8I and 8J,an irritation tool (876) may be utilized to contact-irritate the subjecttissue and induce a subsequent scarring shut of the PFO (802).

Left atrial appendage occlusion is anther cardiac abnormality. One ofthe significant clinical risks associated with atrial rhythmabnormalities is the development of blood clots in the atrial chamberwhich can result in stroke. An anatomic portion of the left atrium,referred to as the left atrial appendage (“LAA”) is particularlysusceptible to clot formation. One approach to eliminate the risk ofclot formation in the LAA is the use of catheter-based devices that arecapable of blocking blood flow and pooling of blood in the LAA, therebyreducing the risk of forming blood clots in the atrium. These devicesmay work well if they could be properly positioned and oriented at theopening of the LAA. Such precise placement can be exceedinglychallenging with conventional catheter techniques. Embodiments of thepresent invention facilitate the process of performing theaforementioned procedure and accurately navigating the devices necessaryto address the LAA. Referring to FIGS. 9A and 9B, a suturing tool (926)may be utilized to close the entrance of an LAA, as facilitated by arobotic instrument assembly such as that depicted (108, 422, 424).Similarly, a clip application tool (936) applying a clip (938),expandable prosthetic tool (946) applying expandable prosthetic (948)(such as that available from Atri-Tech corporation under the trade name“Watchman”, and ablation tool (956) (i.e., to induce tissue welding toshut the entrance of the LAA) may be utilized to address the dangers ofan open LAA, as depicted in FIGS. 9C-9H.

Pacing Lead Placement is another procedure performed to address cardiacabnormalities. Pacemakers have been used in cardiology for many years totreat rhythm abnormalities and improve cardiac function. More recently,many physicians have concluded that synchronistical pacing bothventricles of the heart is, in many patients, more effective thanprovide pacing at one ventricular location of the heart. This techniquerequires that one of the pacing leads be positioned at an optimallocation in the wall of the left ventricle. In order to deliver the leftventricular lead, cardiologists often use a catheter based approach thatdelivers the pacing lead by introducing a cannula or tube into thecoronary sinus. The coronary sinus is a vein that runs along the outsidesurface of the heart. Navigating this coronary sinus vein requiressignificant catheter manipulation and control. In addition, it alsorequires stability of the catheter tip when the proper anatomic locationhas been reached. Embodiments of the present invention facilitateplacement of biventricular leads to their optimal locations to achievethe desired results.

Referring to FIGS. 10A-10B, a sheath (422) and guide (424) instrumentassembly (108) carrying a lead deploying tool (1026) may be advancedacross the tricuspid valve (702) to press a lead (1028) into place at atargeted location (1002), such as a location adjacent the rightventricular apex. Referring to FIGS. 10C-10D, another pacing lead (1030)may be deployed at another targeted position by advancing a guideinstrument (424) with a lead deploying tool (1026) through the coronarysinus (1004) to a desired location, such as a location adjacent orwithin one of the branches off of the coronary sinus in the leftventricular myocardium.

Chronic Total Occlusion (“CTO”) is another cardiac malady or conditionthat may be addressed by using the robotic surgical system (100).Chronic total occlusions generally are blockages of the coronaryvasculature system which prevent blood from passing. These occlusionscreate inadequate blood flow to the region of the heart that derives itsblood from the occluded artery, and forces the affected region tosurvive based on collateral circulation from other vessels. Unlikepartial occlusions, CTOs are difficult to pass a catheter or guide wirethrough because of the lack of any central lumen in the artery. As aresult, conventional therapy of balloon dilation and stent placement isoften impossible to perform, and the atrial lesion may be leftuntreated. Many specialized devices have been developed to try to passthrough the center of a CTO lesion. However, procedures using thesedevices are often lengthy and are associated with significantcomplications and unsuccessful outcomes due to calcification of thelesion or inability to navigate the catheter tip through the center ofthe artery. The subject robotic catheter system (100), because of itsability to precisely control and stabilize the tip of the catheter as itis advanced, facilitates the crossing and removal of CTOs. For example,referring to FIG. 11A, a sheath (422) and guide (424) instrumentassembly (108) may be utilized to advance an RF ablation tool (11026)into position where a CTO (1104) may be ablated with precision anddestroyed and/or removed in a coronary artery (1102). FIG. 11B depictsanother embodiment wherein an RF guidewire (11036) is advanced todestroy and/or remove a CTO (1104) in a coronary artery (1102). FIG. 11Cdepicts another embodiment wherein a laser fiber (11046) is utilized todestroy and/or remove a CTO (1104). FIG. 11D depicts another embodimentwherein a very small grasping tool (11056) is utilized to destroy and/orremove a CTO (1104). FIGS. 11E-11F depict another embodiment wherein acutting/removing tool (11066), such as those available from Fox HollowCorporation is utilized to destroy and/or remove a CTO (1104)

Robotic surgical system (100) may also be used to perform ventricularinjection therapy. Many chronic heart maladies cause progressivedeterioration of heart functions that often resulting in debilitatingand fatal conditions commonly referred as congestive heart failure(“CHF”). In CHF, the heart muscle becomes less efficient, the chambersof the heart begin to dilate and cardiac function tends to deteriorate.As the heart muscle becomes weaker, the heart has to work harder to pumpadequate amount of blood through the circulatory system. The harder theheart has to work, the more damage may be done to its structure andfunction. Typically, clinicians treat CHF with a variety of drugs thatsubstantially decrease blood volume and increase contractility of theheart muscle. Recently, there have been investigations of techniquesthat could repair damaged muscle cells by directly injecting growthfactors or healthy cells into injured or damaged muscles. Thesetechniques have shown some promising results of healing the damagedmuscle; however, these techniques require the drugs to be applieddirectly to the damaged muscle. Accordingly, the needle injector fordelivering the drug to the damaged muscle in the heart must be preciselyand accurate controlled in order to ensure direct delivery of the drugsto the damaged muscle. The subject robotic surgical system (100) is aneffective means for delivering ventricular injections at the preciselocations where clinicians desire to deliver drugs and cell therapies.Referring to FIGS. 12A-912B, an injection tool (12026) may beoperatively coupled to the sheath (422) and guide (424) instrumentassembly (108). The assembly (108, 422, 424, and 12026) is advancedtrans-septally into the left atrium, across the mitral valve, and intothe left ventricle (414), as illustrated in the figures. With the guideinstrument (424) advanced into the left ventricle (414) along with theinjection tool (12026), a precision pattern (1204) of injections may bemade, for example, around an infarcted tissue portion (1202), to startrevascularization and/or rebuilding of such portion. In one embodiment,the pattern (1204) may be in a pattern of a matrix as illustrated inFIG. 12C. Several subsequent treatments may be applied to increase therebuilding of such portion of tissue.

The robotic surgical system (100) may be used to perform a valve repairprocedure. Heart valve disease is a common disorder which affectsmillions of patients and is characterized by a progressive deteriorationof one or more of the heart's valvular mechanisms. Repair of heartvalves has historically been accomplished by open heart surgery.Although such open heart surgery is often successful in improving valvefunction, however, there is also a high risk of death associated withopen heart or heart valve surgeries. Even if such surgery is successful,there is a long period of post-operative recovery associated with openheart surgery. As a result, cardiologists tend to wait as long aspossible before resorting to surgery in patients with deterioratingvalve function.

There is increasing interest in treating valve disease with lessinvasive procedures in order to encourage treatment in the earlierstages of the disease and potentially slow or stop the progression ofheart failure. In recent years, catheter-based procedures have beendeveloped for repairing valves in a surgical manner. As these proceduresdevelop, physicians require a new generation of catheters that can beused like surgical tools and which can be precisely controlled, as maybe provide by the subject robotic catheter system (100). Referring toFIG. 13A, a clip deployer (13026) may be utilized to deploy clips(13028) around the mitral annulus and adjust the geometry of theannulus. FIG. 13B depicts an ablation tool (13036) utilized to inducelocalized ablations to adjust or shrink the geometry of the mitralannulus. Similarly, an ablation tool (13036) may be used to adjust orshrink the geometry of the mitral valve leaflets. FIG. 13C depicts aclip or suture deploying tool (13046), such as those available fromE-Valve Corporation, to position a clip or suture (13048) across themitral leaflets in an Alfieri technique procedure, utilizing theprecision and stability of the sheath (422) and guide (424) of theinstrument assembly (108). FIG. 13D depicts a sheath (422) and guide(424) of instrument assembly (108) delivering a resecting tool (13056)which may be utilized to resect the mitral leaflets and improvecoaptation. FIG. 13E depicts an antegrade approach using a suture tool(13066) to deploy sutures into the mitral annulus to modify the geometryof the mitral valve. FIG. 13F depicts both antegrade and retrogradeinstrument assemblies (e.g., 13066, etc.) to deploy sutures into themitral annulus. FIG. 13G depicts both antegrade and retrograde ablationof the mitral annulus, for example by a bipolar electrode configurationformed by the electrodes carried by the opposing instrument assemblies(e.g., 13066). FIGS. 13H and 13I illustrate the positions of the mitralvalve leaflets may be adjusted by adjusting (e.g., shortening, etc.) thelength of the leaflet chords (13070), chordae tendineae (13070), orpapillary muscle (13072) to ensure proper closure and/or alignment ofthe leaflets to prevent leakage by using a clip tool (13026) to deploy aclip (13028), an ablation tool (13036), a suturing tool (13046), etc.

FIG. 14 depicts an ablation tool (14026), similar to the description andprocedure as described above, modifying the geometry of the tricuspidvalve (702). The configurations of tools similar to those as illustratedin FIGS. 13A-13G may be utilized on the tricuspid valve (702).

FIG. 15A through FIG. 5D depict a robotic instrument assembly (108)using a retrograde approach to deploy an expandable aortic valveprosthetic (15028). Alternatively, FIG. 15E through FIG. 15J illustratea robotic instrument assembly (108) being used by way of the inferiorvena cava through the septum and the mitral valve, and then going up theaorta to deploy an expandable aortic valve prosthetic (15028) in theaorta. The methods as described may be referred a “single-handed”approach. That is, the expandable aortic valve prosthetic (15028) may bedeployed by the method as illustrated in FIGS. 15A through 15D or themethod as illustrated in FIG. 15E through FIG. 15J using one instrumentassembly (108). Alternatively, the expandable aortic valve prosthetic(15028) may be deployed using a “two-handed” approach. That is, theexpandable aortic valve prosthetic may be deployed using two roboticinstrument assemblies (108). For example, a first instrument assembly(108) may be used to position or adjust the placement of the aorticvalve prosthetic (15028) while a second instrument assembly (108) may beused to place the aortic valve prosthetic. FIG. 15K, illustrates oneembodiment of a two-handed approach. As illustrated in FIG. 15K, anexpandable valve prosthetic (15028) is being deployed by a firstinstrument assembly (108-422, 424) using a retrograde approach asillustrated in FIG. 15A through FIG. 15D. At the same time, a secondinstrument assembly (108-422, 424) with a positioning apparatus (e.g., aballoon with a scope, etc.) approaches the aortic valve (406) fromdifferent direction of deployment for the valve prosthetic (15028), suchthat the positioning apparatus assists with the placement or positioningof the prosthetic (15028) as it is being deployed.

In addition, the robotic surgical system (100) including the controlstation (102), instrument driver (106), instrument (108), and the wiredconnection (112) may be used to treat other diseases, maladies, orconditions in the tissues or organs of the digestive system, colon,urinary system, reproductive system, etc. For example, the roboticsurgical system (100) may be used to perform Extracorporeal Shock WaveLithotripsy (ESWL). FIG. 16 illustrates one embodiment of instrument(108) configured to perform ESWL. As illustrated in FIG. 16, instrument(108) may include a sheath catheter (422), a guide catheter (424), and alithotripsy laser fiber (16026). Analogous to the discussion above,components or subsystems of the instrument (108) may be guided,manipulated, or navigated to the kidney to perform various operations.For example, subsystems of the instrument (108) may be guided,manipulated, or navigated to the kidney to remove kidney stones asoppose to similar components or subsystems of embodiments of theinstrument (108), e.g., an ablation catheter, being guided, manipulated,or navigated to the left atrium of the heart to performing cardiacablation to address cardiac arrhythmias. The lithotripsy laser fiber(16026) may include a quartz fiber coupled, connected to, or associatedwith a laser, such as a Holmium YAG laser, to apply energy to objectssuch as kidney stones, etc. In one configuration, the laser source maybe positioned and interfaced with the fiber (16026) proximally, as in atypical lithotripsy configuration, with the exception that in thesubject embodiment, the fiber (1602) is positioned down the workinglumen of one or more robotic catheters (e.g., sheath catheter (422) andguide catheter (424)). All the necessary power source and controlmechanisms including hardware and software to operate the laser may belocated in the electronics rack (114) near the operator control station(102) of the robotic surgical system (100)

Since the distal tip of the lithotripsy fiber (16026) is configured todeliver energy to a target object, such as a kidney stone, the distaltip may be more generically described as an energy source. Indeed, inother embodiments, other energy sources, besides a laser, may be used toaffect tissue. For example, in other embodiments, the energy source maybe comprised of an RF electrode, an ultrasonic transducer, such as ahigh-frequency ultrasonic transducer, or other radiative, conductive,ablative, or convective energy source.

As may appreciated, the components or subsystems of instrument (108) maybe configured with numerous different instruments or tool for performingvarious minimally invasive operations. For example, FIG. 17 depicts aguide instrument (424) operatively coupled to a grasper (17026) fittedwith an energy source (17036), such as a lithotripsy laser fiber (16026)in a configuration wherein an object, such as a kidney stone, graspedwithin the clutches of the grasper (17026), may also be ablated,destroyed, fragmented, etc, by applied energy from the source (17036),which is positioned to terminate approximately at the apex of thegrasper (17026) which it is likely to be adjacent to captured objects.

FIG. 18 depicts a similar configuration as the instrument assembly (108)including the sheath (422) and guide (424) that is illustrated in FIG.17. FIG. 18 illustrates a basket tool (18026) and energy source (17036),such as a lithotripsy fiber (16026), positioned through the workinglumen of the guide instrument (424). In each of the configurationsdepicted in FIG. 17 and FIG. 18, the energy source (17036) may becoupled to the pertinent capture device, or may be independentlypositioned through the working lumen of the guide instrument (424) tothe desired location adjacent the capture device (17026, 18026). Each ofthe tools described herein, such as graspers, baskets, and energysources, may be controlled proximally as they exit the proximal end ofthe working lumen defined by the guide instrument (424), or they may beactuated manually, automatically or electromechanically, for examplethrough the use of electric motors and/or mechanical advantage devices.For example, in one embodiment, a configuration such as that depicted inFIG. 18, the sheath (422) and guide (424) instruments are preferablyelectromechanically operated utilizing an instrument driver (106) (notshown in these two figures) such as that described in the U.S. patentapplication Ser. No. 11/481,433, which is incorporated herein byreference in their entirety. The grasping mechanisms (17026, 18026) maybe manually actuated, for example utilizing a positioning rod andtension wire, or electromechanically operated using a servomechanism orother proximal actuation devices. The energy source (17036) may beoperated proximally utilizing a switch, such as a foot pedal or consoleswitch, which is associated with the proximal energy control device (notshown in FIGS. 17 and 18).

FIG. 19 depicts an expandable grasping tool assembly (19026) with anenergy source (17036, 16026) mounted at the apex of the graspermechanism. The energy source (17036, 16026) is proximally associated, byone or more transmission leads (1904), such as a fiber or wire, with adevice (1902) such as an RF generator or laser energy source. Theopposing jaws (19024) of the depicted grasping tool assembly (19026) arebiased to spring outward, thus opening the grasper when unbiased. Whenpulled proximally into a confining structure, such as a lumen of a guideinstrument (424), the hoop stress applied by the confining structureurges the jaws (19024) together, creating a powerful grasping action.

FIG. 20 depicts a bipolar electrode grasper with a proximally associatedRF generator or other energy source (2002). In this embodiment, each ofthe jaws (19024) is biased to swing outward, as in the embodimentdepicted in FIG. 19, and each of the jaws (19024) also serves as anelectrode for the bipolar pairing, to be able to apply energy to itemsor objects which may be grasped. Leads (2004) are depicted to couple thejaws (19024) with a proximally positioned energy source (2002), such asan RF generator

FIG. 21 depicts a sheath instrument (422) coupled to a group of basketarms (2102) that are biased to bend inward (i.e., toward thelongitudinal axis of the sheath/guide as depicted), and configured tograsp a stone or other object as the guide instrument (424) is withdrawnproximally into the sheath instrument (422). The depicted embodimentfeatures an image capture device (2104) which may or may not have a lens(2106), illumination fibers (2108) to radiate light, infrared radiation,or other radiation, and a working lumen (2110) for positioning toolsdistally. The image capture device (2104), which may comprise afiberscope, CCD chip, infrared imaging device, such as those availablefrom CardioOptics Incorporated, ultrasound device, or other imagecapture device, may be used, for example, to search for objects such asstones, and when located, the guide instrument (424) may be withdrawninto the sheath instrument (422) to capture the object, which the entireassembly is gently advanced to ensure that the object remains close tothe distal tip of the assembly for easy capture by the basket device(2102)

FIG. 22 depicts an assembly comprising a lithotripsy fiber (2202) andimage capture device (2204) configured to enable the operator to see anddirect the laser fiber (2202) to targeted structures, utilizing, forexample, the high-precision navigability of the subject sheath (422) andguide (424) instrument assembly (108), and apply energy such as laserenergy to destroy or break up such structures. Preferably the imagecapture device (2204) is positioned to include the position at which theenergy source (such as a lithotripsy fiber 2202) as part of the field ofview of the image capture device (2204)—i.e., to ensure that theoperator can utilized the field of view to attempt to bring the energysource into contact with the desired structures.

FIG. 23 depicts a similar embodiment as the one shown in FIG. 22, whichincludes a grasping tool (2302) to grasp a stone or other object andbring it proximally toward the image capture device (2204), such that itmay be examined, removed proximally through the working lumen of theguide instrument (424), etc.

FIG. 24 illustrates another similar embodiment, which includes a baskettool (2402). FIG. 25 and FIG. 26, illustrate how an embodiment such asone depicted in FIG. 24 may be used to grasp and retrieve stones orother objects toward the distal portion of the guide (424). As theretrieved object approaches the guide (424), energy source (17036,16026) breaks up the object in the basket tool (2402); this operation issimilar to the operation in the embodiment illustrated in FIG. 18.

FIG. 27 depicts an embodiment with a proximal basket arm capture (2102)and an image capture device (2108). As described above in the portion ofthe description describing FIG. 21, when an object is observed with theimage capture device (2108), the entire assembly may be advanced whilethe guide instrument (424) is withdrawn proximally into the sheathinstrument (422) until the depicted basket capture arms (2102) are ableto rotate toward the central axis of the guide instrument (424) workinglumen and capture objects positioned adjacent the distal tip of theguide instrument (424)

FIG. 28 depicts a configuration with an inflatable balloon (2802)configured to be controllably filled with or evacuated of saline (2804),through which an image capture device (2204) and illumination source(2806) may be utilized to observe objects forward of the balloon thatpreferably fall within the field of broadcast (2808) of the illuminationsource (2806) and field of view (2810) of the image capture device(2204). The balloon (2802) also defines a working lumen (2812) throughwhich various tools may be passed—such as a laser fiber (2202), asdepicted. FIG. 29 depicts a similar embodiment also comprising agrasping tool (2302). FIG. 30 depicts a similar embodiment with a baskettool (2402).

FIG. 31 through FIG. 33 depict similar embodiments which comprise aninflatable balloon cuff (3102) configured to provide a distal workingvolume (3104) which may be flushed with a saline flush port (2806). Theinflatable balloon cuff (3102) preferably works not only as anatraumatic tip, but also as a means for keeping the image capture device(2810) positioned slightly proximally of structures that the inflatableballoon cuff (3102) may find itself against—thus providing a smallamount of volume to image such structures without being immediatelyadjacent to them. With an optical fiberscope as an image capture device(2810), it may be highly valuable to maintain a translucentsaline-flushed working volume (3104) through which the image capturedevice (2810) may be utilized to image the activity of objects, such astissues and/or kidney stones, as well as the relative positioning oftools, such as fibers, graspers, baskets, etc., from proximal positionsinto the working volume (3104)—which may be used, for example, to graspand/or modify or destroy stones or other structures. The inflatableballoon cuff (3102) may be advanced to the desired operational theater,such as the calices of a kidney, in an uninflated configuration, andthen inflated in situ to provide the above functionality. Alternatively,the cuff (3102) may be inflated before completing the navigation to theoperational theater, to provide atraumatic tip functionality as well asimage capture guidance and deflection from adjacent objects, duringnavigation to the desired operational theater.

FIG. 34 through FIG. 36 depict similar embodiments, but with a flexiblecuff (3402), preferably comprising a soft polymer material, rather thanan inflatable cuff (3102) as in the previous set of figures. Theflexible cuff (3402) is configured to have similar functionalities asthose described in reference to the inflatable cuff (3102) above.

FIG. 37 through FIG. 41 depict an embodiment wherein an assembly of animage capture device (2104), which may optionally comprise a lens(2106), transmission fibers (2108) for imaging, and a working lumen(2110), through which various tools or combinations of tools may bepositioned. The components of this embodiment are all packaged withinone tubular structure as illustrated in the cross sectional view of FIG.41, which may comprise a co-extruded polymeric construct. FIG. 38through FIG. 40 depict the interconnectivity of an image capture device(2104), such as a fiberscope comprising a proximal optics fitting(3802), an optics body member (3804), a proximal surface (3806) forinterfacing with a camera device with the illumination fibers andworking lumen, comprising a female luer fitting (3808) for accessing theworking lumen (2110), a working lumen proximal member (3810), anillumination input tower (3812), an insertion portion (3814), a centralbody structure (3816). Variations of this embodiment are depicted inFIG. 42 through FIG. 45, with different distal configurations similar tothose depicted in reference to the figures described above. FIG. 42depicts a variation having a distally-disposed flexible cuff (3402)defining a working volume (3104) flushable with a saline port (2806) andimaged with an image capture device (2810) as described above. FIG. 43depicts a similar variation having an inflatable cuff (3102). Tools suchas graspers, energy sources, fibers, baskets, etc may be utilizedthrough the working lumens (2110) of the embodiments depicted in FIG.42, FIG. 43, FIG. 44, FIG. 45, etc. The embodiment of FIG. 44 comprisesa grasping tool (2302) positioned through the working lumen of theassembly (2104—the assembly depicted in FIG. 37 through FIG. 41), whichthe embodiment of FIG. 45 comprises a basket tool (2402).

Each of the above discussed tools, configurations, and/or assemblies maybe utilized for, among other things, endolumenal urinary intervention,such as the examination, removal, fragmentation, and/or destruction ofstones such as kidney or bladder stones.

Referring to FIG. 46A, a steerable instrument assembly according to oneembodiment may be steered through the urethra (4602) and into thebladder (4604), where an image capture device (2810) may be utilized, asfacilitated by injected saline, to conduct a cystoscopy and potentiallyobserve lesions (4606) of interest. The omni-directional steerabilityand precision of the robotic guide and/or sheath to which the imagecapture device is coupled facilitates collection of images of inside ofthe bladder (4606) which may be patched together to form a 3-dimensionalimage. The instrument assembly (108-422, 424, 2810) may also be utilizedto advance toward and zoom the image capture device upon any defects,such as obvious bleeds or tissue irregularities. Indeed, aspects of theimages captured utilizing the image capture device (2810) may beutilized in the controls analysis of the subject robotic catheter systemto automate, or partially automate aspects of the system/tissueinteraction. For example, as described above, more than onetwo-dimensional image may be oriented relative to each other in space toprovide a three-dimensional mosaic type composite image of a subjecttissue mass, instrument, or the like. Localization techniques may beutilized to assist with the “glueing together” of more than one image;for example, spatial coordinates and orientation may be associated witheach image captured by the image capture device, to enable re-assemblyof the images relative to each other in space. Such a three-dimensionalcomposite image may be registered in three dimensions to the workspaceor coordinate system of the subject elongate instrument or instrumentassembly, to provide automated display, zooming, and reorientation ofthe images displayed relative to the distal portion of the elongateinstruments as the instruments are moved around in the workspace.Further, the system may be configured to update the composite image withmore recently-captured images as the instruments are navigated about inthe workspace. Image recognition algorithms may be utilized to bolsterthe information gleaned from image capture; for example, a substantiallyround and dark shape in a particular location known to be at leastrelatively close to a lumen entry into or exit from a particularanatomic space may be analyzed and determined via application of thepertinent algorithms to be a given lumen entry or exit anatomicallandmark, and the location of such landmark may be stored on a databasealong with the position and orientation variables of the elongateinstruments utilized in the particular instance to arrive at suchlocation—to enable easy return to such location using such variables.The system may thus be configured to allow for automated return of theinstruments to a given landmark or other marker created manually orautomatically upon the composite image and associated database. Further,given the composite image of the actual tissue in-situ, the system maybe configured to not only to allow for the storage of and return tocertain points, but also for the creation and execution of configurable“keepout zones”, into which the instruments may be disallowed undernavigation logic which may be configured to prevent touching of theinstruments to certain tissue locations, navigation of the instrumentsinto particular regions, etc. Similar procedures may be performed in theprostate (4608) as illustrated in FIG. 46B.

Referring to FIG. 47, the instrument assembly (108-422, 424, 4702) mayalternatively or additional comprise an interventional tool such as anablation tool (4702) for ablating tumors or other lesions (4606) withinthe bladder (4604) or prostate (4608). Any of the above-discussedassemblies may be utilized for such a cystoscopy procedure.

Each of the above-discussed constructs may also be utilized adjacent toor within the kidneys. Referring to FIG. 48 and FIG. 49, forillustrative purposes, a portion of a relatively simple instrumentassembly embodiment (for example, a sheath distal tip may be positionedin the bladder at the entrance to the urethra while the more slenderguide, 424, is driven toward and into the kidney, 4802) is depicted.Such assembly may be advanced toward and/or steerably driven into thekidney (4802), where stones (4804) may be captured with graspers orother tools, or where stones may be destroyed using chemistry, cryo, RF,laser lithotripsy, or laser ablation tools (4806), or other radiativetechniques, such as ultrasound, as depicted in FIG. 48 and FIG. 49. Eachof the tools, configurations, and/or assemblies discussed above inreference to FIG. 16 through FIG. 45 may be utilized for theexamination, removal, fragmentation, and/or destruction of stones suchas kidney or bladder stones. Preferably, an image capture device (2810)is positioned in or adjacent to the calices of the kidney to enableinteractive viewing of objects such as stones, while various toolconfigurations may be utilized to examine, capture, grasp, crush,remove, destroy, etc, such stones, before withdrawing the instrumentassembly.

Additional instruments and tools may be operatively coupled to theinstrument (108) to perform various minimally invasive surgicalprocedures. As may be appreciated, the instruments and tools may beoperatively coupled to manually or robotically operated instruments(108). FIG. 50A illustrates one embodiment of a sheath (422) and guide(424) instrument (108) assembly that is operatively coupled to conicalballoon instrument (5002), wherein the conical balloon is in a retractedconfiguration. In this embodiment, the balloon (5002) may be deployed byextruding the balloon structure (5002) from the distal tip of the guidecatheter (424) and extricated by pulling the balloon structure (5002)back into the guide catheter (5002). FIG. 50B illustrates the embodimentshown in FIG. 50A wherein the retracted conical balloon (5002) is in adeployed configuration.

FIG. 51 illustrates one embodiment of a sheath (422) and catheter (424)of the instrument assembly (108) with a deflated balloon (5102). In oneembodiment, the balloon is deployed by inflating the balloon (5102) witha gas or liquid. For example, the balloon may be inflated by air, carbondioxide, saline, contrast agent, etc., but is not limited as such. FIG.52 illustrates a sheath (422) and catheter (424) with one embodiment ofan inflated balloon (5202). In this example, an image capture device(5204) is located in the working lumen of the catheter (424). A user canmanipulate the proximal end of the image capture device (5204). Thedevice (5204) may be maneuvered about the interior of the balloon (5202)to view various areas. For one embodiment, the balloon (5202) isinflated with a gas or liquid that allows for visibility through it. Inother words, the balloon (5202) is inflated with an appropriate materialwherein the image capture device (5204) can operate properly and captureimages with sufficient detail. For example, the balloon may be placednear or against tissues in the body of a patient to facilitatediagnostic or interventional operations. FIG. 53 illustrates a sheath(422) and catheter (424) with one embodiment of a toroid shaped balloon(5302). The balloon (5302) of this embodiment includes a lumen (5304)through its center and allows for the deployment of items such as tools,catheters, contrast agent, solutions, etc. from the proximal end of thecatheter (424).

FIG. 54 illustrates a sheath (422) and catheter (424) with distal tipportion (5402) of the catheter (424) where a balloon may be deployed ishighlighted. The discussion that follows below for FIG. 55 through FIG.87 is described in the context of the distal tip portion (5402) of thecatheter (424). Although various types of material may be used toconstruct the balloon, it may be preferably in some embodiments to use apolyamide material that allows for the transmission of light through thematerial or a material that is optically transparent. For instance, itmay be desirable to view tissues of an organ in a patient through thesurface of an inflated balloon with an image capture device.

FIG. 55 illustrates one embodiment of an inflated conical shaped balloon(5502) manufactured by a heat bonding process. For example, theinflatable chambers are joined by a heat bonding by process. In thisembodiment of a balloon (5502) implementation, the balloon (5502) isconstructed with three inflatable chambers (5504A, 5504B, 5504C) througha heat bonding process. The chambers (5504A, 5504B, 5504C) are orientedaround the axis of the catheter (424). In one embodiment, the pressurefor each one of the three chambers may be independently controlled, thusallowing each chamber to be inflated to a different or the same pressureas the other chambers. In another embodiment, the three chambers may beall inflated to the same pressure. Depending on the balloon design, thechambers may function independent of the others wherein puncturing oneof the chambers will not affect the other chambers.

FIG. 56 illustrates another embodiment of a conical shaped balloon(5602). Similar to the balloon (5502) illustrated in FIG. 55, thisballoon (5602) is also constructed with a plurality of inflatablechambers (5604) by a heat bonding process. The chambers (5604) of thisembodiment extend laterally along the axis of the catheter (424). FIG.57 illustrates one embodiment of a cylindrical shaped balloon (5702)manufactured by a heat bonding process. The chambers (5704) of thisembodiment also extend laterally along the axis of the catheter (424).Due to the cylindrical shape of the balloon (5702) of this embodiment,each of the chambers (5704) may be similar to the others in dimensionsand capacity, whereas the chambers of the balloons illustrated in FIG.55 and FIG. 56 may have different dimensions and capacities.

FIG. 58 illustrates one embodiment of a conical shaped balloon (5802)having two or more chambers (5804-1, 5804-2 . . . , 5804-n) that may beinflated to the same or different pressures. In one embodiment, theproximal chamber (5804-1) may be inflated to a higher pressure than thesecond chamber (5804-2). It may be desirable to inflate the secondchamber (5804-2) to a lower pressure because the second chamber may comeinto contact with tissue and rest against the tissue, such that thelower pressure of the chamber (5804-2) could make a substantially softercontact with a tissue surface. As may be appreciated, it may bedesirable in some applications or procedures to have a softer contactwith the surface of tissues. FIG. 59 illustrates one embodiment of aconical shaped balloon (5902) having one inflatable chamber (5904-1) anda soft distal section (5904-2). The soft distal section (5904-2) may beslightly softer than the inflatable chamber (5904-1). In one embodiment,the soft distal section (5904-2) may be a curtain or skirt constructedwith a soft polyamide material or plastic having a relatively lowDurometer hardness value.

Depending on the construction of a balloon, some reinforcement may bedesirable in certain instances. For example, a user may not want aballoon to collapse during a procedure or a particular procedure mayrequire the balloon to provide a minimal level of rigidity. FIG. 60illustrates one embodiment of a conical shaped balloon (6002) having astructural reinforcement wire (6004) deployed within balloon (6002). Inone instance, the wire (6004) is woven into the surface of the balloon(6002). In this example, the wire (6004) may be a coil that extends fromthe distal tip of the catheter (424) through the balloon (6002) to thedistal edge of the balloon (6002). FIG. 61 illustrates one embodiment ofa cup shaped balloon (6102) having a stent type of reinforcement (6104).In this embodiment, the stent structure is built into the balloon bodyand is collapsible. By pulling the balloon (6102) back into the distaltip of the catheter (424), the stent structure collapses. To deploy theballoon (6102), the balloon (6102) is pushed out from a working lumen orchannel of the catheter (424) and the stent structure expandsautomatically. FIG. 62 illustrates one embodiment of a cylindricalshaped balloon (6202) having a stent type of reinforcement (6204).

FIG. 63 illustrates one embodiment of a cup shaped balloon (6302) havinglateral support rings (6304). In this example, the ring supports areconstructed of a polyamide material and located within the sidewalls ofthe balloon (6302). For one embodiment, the support rings (6304) areapproximately the same size. In other embodiments, the support rings(6304) may vary in size depending on its designated location within theballoon (6302). FIG. 64 illustrates one embodiment of a cup shapedballoon (6402) having a first chamber (6404) with a stent typereinforcement structure and a distal second chamber (6406) without thestent type reinforcement. In this example, both chambers (6404, 6406)may be inflated to the same or different pressures. For oneimplementation, the distal second chamber (6406) is inflated to apressure sufficiently low such that the surface of the second chamber(6406) may be pliable or relatively soft when in contact with tissue.FIG. 65 illustrates one embodiment of a cup shaped balloon (6502) havinga first chamber (6504) with a stent type reinforcement structure and adistal edge (6506) constructed of a soft material. In this embodiment,the distal edge is constructed with a soft pliable polyamide material.

FIG. 66 illustrates one embodiment of a cup shaped balloon (6602)together with an image capture device (6604) and flush port (6606) atthe distal tip of a catheter (424). The cup shape of this embodimentallows for the creation of a working volume (6608). By placing thedistal edge of the balloon (6610) up against tissue, a working volume(6608) is formed by the surface of the tissue and the inner surface ofthe balloon (6612). Although the working volume (6608) may contain bloodduring some procedures, the blood may be evacuated by flushing theworking volume (6608) by injecting saline or carbon dioxide through theflush port (6606). With the working volume (6608) cleared, the imagecapture device (6604) may be used to examine the surrounding tissue.FIG. 67 illustrates one embodiment of a catheter (424) having a cupshaped balloon (6602) together with an image capture device (6604), aflush port (6606), and a working lumen (6702) at the distal tip of acatheter (424). The working lumen (6702) is a hollow channel in whichtools or surgical instruments may be passed from the proximal end of thecatheter (424) to the distal end of the catheter (424) to performoperations in the working volume (6608) of the balloon (6602).

FIG. 68 illustrates one embodiment of a toroid shaped balloon (6802)with a suction port (6804) at the distal tip of a catheter (424). Theballoon (6802) of this embodiment includes a working volume (6806) thatcan be evacuated by suctioning out the contents therein when the distalsurface of the balloon (6802) is up against a surface. Furthermore, thesuction provided by the suction port (6804) may allow the balloon to beanchored to a surface if a sufficient vacuum force is created in theworking volume (6806).

FIG. 69 illustrates one embodiment of a balloon (6902) that includescollapsible support ribs (6904).

FIG. 70 illustrates one embodiment of a two layered balloon (7002)together with an image capture device (6604) at the distal tip of acatheter (424). In this embodiment, the balloon (7002) has an outerlayer (7004) and an inner layer (7006). Encapsulated between the twolayers (7004, 7006) is a space (7008) which may be filled with a salinesolution or a gas medium, e.g., carbon dioxide, etc. Preferably, thesolution/gas medium encapsulated between the layers (7004, 7006) as wellas the material of the balloon and the combination thereof, aretransparent to the image capture device (6604), such that image capturedevice (734) would be able to “view” tissue outside of the balloon(7002). The image capture device (6604) may be any suitable imagecapturing device, e.g., optical, ultrasound, laser, CCD, etc.

FIG. 71 illustrates one embodiment of a side firing ultrasoundtransducer catheter (7102) enclosed within an inflated balloon (7104) atthe distal tip of a catheter (424). In this embodiment, ultrasoundtransducer elements (7106) are mounted on the circumferential surface ofthe transducer catheter.

FIG. 72 illustrates one embodiment of a balloon (7202) with a pluralityof spikes (7204) at the distal tip of a catheter (424). In oneembodiment, the spikes (7204) may be employed to temporarily anchor aninflated balloon (7202) to a tissue structure. The catheter (424) ofthis embodiment includes a first lumen (6702) and a second lumen (7206).As with other lumens, each can be used to transfer tools, imagingdevices, catheters, illumination fibers, etc. from the proximal end ofthe catheter (424) to the distal tip. FIG. 73 illustrates one embodimentof a balloon (7302) with spines (7304) at the distal tip of a catheter(424). The spines (7304) may be employed for anchoring the balloon(7302) like the spikes (7204) discussed directly above.

FIG. 74 illustrates one embodiment of an image capture device (7404)with a reticle (7406) and illumination fibers (7408) enclosed within aballoon (7402) at the distal tip of a catheter (424). The depictedembodiment features an image capture device (7404) which may or may nothave a lens. The illumination fibers (7408) may radiate light, infraredradiation, or other radiation to illuminate an area of interest. Theimage capture device (7404), which may comprise a fiberscope, CCD chip,infrared imaging device, such as those available from CardioOpticsIncorporated, ultrasound device, or other image capture device, may beused, for example, to search for objects such as stones. In oneembodiment, the reticle (7406) allows for the measurement of interestingtissue structures. FIG. 75 illustrates one embodiment of an articulatingendoscope (7502) enclosed within a balloon (7402) at the distal tip of acatheter (424). The articulating endoscope (7502) of one embodiment may,in addition to moving in and out relative to the distal tip of thecatheter (424); it is capable of additional manipulations, e.g., bend,roll, and pitch, within the volume defined by the balloon in order toaccess any desired position or area on the balloon surface.

FIG. 76 illustrates one embodiment of a laser fiber (7602) and an imagecapture device (6604) enclosed within a balloon (7402) at the distal tipof a catheter (424). In one embodiment, the laser fiber may be alithotripsy laser fiber. Such a fiber may comprise a quartz fiber and beassociated with a laser, such as a Holmium YAG laser, to apply energy toobjects such as kidney stones. In one configuration, the laser source ispositioned and interfaced with the fiber (16026) proximally, as in atypical lithotripsy configuration, with the exception that in thesubject embodiment, the fiber is positioned down the working lumen ofone or more robotic catheters. Since the distal tip of the lithotripsyfiber is configured to deliver energy to a target object, such as akidney stone, the distal tip may be more generically described as anenergy source. Indeed, in other embodiments, other energy sources,besides laser, may be utilized to effect tissue. For example, in otherembodiments, the energy source may comprise an RF electrode, anultrasound transducer, such as a high-frequency ultrasound transducer,or other radiative, conductive, ablative, or convective energy source.

FIG. 77 illustrates one embodiment of an image capture device (6604) andillumination fibers (7408) enclosed within a balloon (7702) having aplurality of magnifying lenses (7704) positioned at various locations onthe balloon surface. When using the image capture device to viewstructures outside of the balloon during a procedure, one of themagnifying lenses may be maneuvered in the direction of the desireditem. By positioning the image capture device to look at the itemthrough the appropriate magnifying lens, the object may be magnifiedwithout the use of an additional magnifying apparatus on the catheter orsystem.

FIG. 78 illustrates one embodiment of a balloon (7802) having a radiofrequency (RF) electrode (7804) deployed on its surface. In oneprocedure, the balloon may be positioned up against the target tissue.By maneuvering the electrode (7804) to the appropriate orientation andposition, the target tissue may be ablated.

FIG. 79 illustrates one embodiment of a balloon (7902) having a magnet(7904) on its outer surface. Magnetic energy may be used to treattissues in a patient.

FIG. 80 illustrates one embodiment of balloon (8002) having a pair ofmapping electrodes (8004, 8006) mounted on the outer surface of theballoon. The mapping electrodes (8004, 8006) may be used to map thesurface tissues or organs in a patient.

FIG. 81 illustrates one embodiment of a balloon (8102) having a throughlumen (8104). Also located within the balloon (8102) are illuminationfibers (7408) and an image capture device (6604). FIG. 82 illustratesone embodiment of a balloon (8102) having an ablation tool (8106)deployed in its through lumen (8104). FIG. 83 illustrates one embodimentof a balloon (8102) having a grasper (8108) deployed in its throughlumen (8104). The grasper (8108) of one embodiment may be fitted with anenergy source, such as a lithotripsy laser fiber in a configurationwherein an object, such as a kidney stone, grasped within the clutchesof the grasper (8108) may be ablated, destroyed, fragmented, etc., byapplied energy from the source, which is positioned to terminateapproximately at the apex of the grasper (8108) which it is likely to beadjacent to captured objects. FIG. 84 illustrates one embodiment of aballoon (8102) having a basket tool (8110) deployed in its through lumen(8104). The energy source may be coupled to the pertinent capturedevice, or may be independently positioned through the working lumen ofthe guide instrument (424) to the desired location adjacent the capturedevice. Each of the tools described herein, such as graspers, baskets,and energy sources, may be controlled proximally as they exit theproximal end of the working lumen defined by the guide instrument (424),or they may be actuated automatically or electromechanically, forexample through the use of electric motors and/or mechanical advantagedevices.

FIG. 85 illustrates the distal tip of one embodiment of a catheter (424)having a balloon (8502) and an ablation catheter (8106) deployed in aworking lumen located outside of the balloon (8502). In this embodiment,illumination fibers (7408) and an image capture device (6604) is locatedwithin the confines of the balloon (8502). FIG. 86 illustrates thedistal tip of one embodiment of a catheter (424) having a balloon (8502)and a grasper (8108) deployed in a working lumen located outside of theballoon (8502). FIG. 87 illustrates the distal tip of one embodiment ofa catheter having a balloon (8502) and a basket tool (8110) deployed ina working lumen located outside of the balloon (8502).

All of the aforementioned tools and instruments, e.g., balloons,ablation tools, baskets, graspers, scopes, etc. apparatuses areconfigured to be operatively coupled to the instrument assembly (108) incombination with the sheath catheter (422) and guide catheter (424). Insome embodiments, the tools and instruments may be used with the guidecatheter (424) without the sheath catheter (422). In other embodiments,additional catheters may be used with the tools and instruments. Asapparent to one skilled in the art, the tools and instruments areconfigured to be either manually operated or robotically operated by theinstrument driver (106) in connection with the instrument (108). Some ofthe circuitry, e.g., electrical, mechanical, hardware, software,firmware, etc. systems for controlling and operating all of theaforementioned tools and instruments may be configured at the instrumentdriver (106) and the system electronics rack (114).

FIG. 88 through 90 illustrate various views of one embodiment of a mold(8802) for manufacturing a balloon. FIG. 88 illustrates a side view ofthe mold (8802) for manufacturing the balloon. In one embodiment, theballoon is formed over the ball structure towards the bottom of themold. FIG. 89 illustrates a top view of the mold (8802). FIG. 90illustrates an isometric view of the mold (8802).

FIG. 91 through FIG. 95 illustrate one embodiment of a method fordeploying an angioplasty ring (9116) using a balloon apparatus (9110,9112), within the balloon apparatus may be similar to the embodimentdescribed in FIG. 74. That is, the balloon apparatus includes an imagecapture device 7404 to enable visual access through the balloon. In thisembodiment, the balloon portion (9110) of the balloon apparatus (9110,9112) is used to hold the ring (9116) in place while the ring is beingdeployed by a second catheter (9106). For example, an angioplasty ring(9116) may be applied to the mitral annulus (9104) near the mitral valveof the heart (9102). As illustrated in FIG. 91, a catheter (9106) may bemaneuvered toward the mitral valve by the guide catheter (424). A ringapplicator (9108) at the distal portion of the catheter (9106) isposition near the mitral annulus (9104) by the mitral valve. The balloonapparatus (9110) deployed by the catheter (9112) moves the ringapplicator (9108) into position over the mitral annulus (9104). Once thering applicator (9108) is in position, the ring (9116) is secured inplace by one or more clips (9114). The ring (9116) or the clip (9114)may be adjusted, e.g., by tension wires (not shown), to clinch the ringmore tightly on the mitral annulus (9104) around the mitral valve.

FIG. 96 illustrates one embodiment of a method for ablation using aballoon apparatus. In this embodiment, the ablation catheter (9604)travels around the outer edge of the first balloon (9606) to ablate thedesired tissue at an operation site (9602).e.g., pulmonary vein. Asecond catheter or balloon (9608) may be used to anchor the firstballoon (9606)) to the pulmonary vein. In this example, the firstballoon (9606) serves as a guide for the ablation catheter (9604).

FIG. 97 illustrates one embodiment of a catheter (9702) with a toroidshaped balloon (9704) deployed at its distal tip and an ablationcatheter (9706) for performing various ablation procedures. The catheter(9702) may be advanced to the operation site with the balloon (9704)initially in a deflated or undeployed configuration. Once the catheter(9702) is advanced to the operation site, the balloon (9704) may beinflated or deployed using a suitable medium, e.g., saline solution,air, etc., to position or secure the catheter (9792). An ablationoperation may be performed using the ablation catheter (9706).

FIG. 98 illustrates one embodiment of a catheter (9702) with a circularshaped balloon (9802) with an electrode strip (9804) mounted on itsouter surface. In one embodiment, the electrode strip is employed forperforming ablation procedures.

FIG. 99 illustrates one embodiment of a method for RF mapping with aballoon (9902) mounted with electrodes (9904-1, 9904-2 . . . , 9904-n).Depending on the specific circuitry coupled to each of the electrodesand the signal commands to operate the electrodes, different proceduresmay be accomplished using the electrodes (9904-1, 9904-2 . . . ,9904-n). In one embodiment, the electrodes (9904-1, 9904-2 . . . ,9904-n) may be used for mapping a cavity or the interior volume of anorgan of a patient to generate a three-dimensional map of the cavity orinterior volume. In a second embodiment, the electrodes may be used forperforming ablation procedures on tissues of an organ in a patient. FIG.100 illustrates a portion of the top surface of the balloon (9902) thatwas illustrated in FIG. 99

FIG. 101 through FIG. 104 illustrate one embodiment of a method forperforming a patent foramen ovale (PFO) procedure using a balloonapparatus. As illustrated in FIG. 101, a first catheter with (10102) theballoon structure (10104) travels up the inferior vena cava to the rightatrium. This balloon (10102) includes a magnet (10106) mounted on itssurface. A second catheter (10108) travels to the left atrium of theheart through a retro grade path. The two catheters meet at the wallseparating the atriums as illustrated in FIG. 101 and FIG. 104. Thesecond catheter (10108) may include a metallic material at its distalportion, such that the magnet (10106) on the balloon (10102) may beattracted to the distal portion of the catheter (10108) against thetissue (1114) and substantially holding and positioning the balloon(10102) at a desired location against the tissue (1114). FIG. 102 andFIG. 103 illustrate the balloon apparatus (10102) includes a scope(10110) and a needle or an ablation instrument (1112). As the balloon(10102) is held at a substantially desired location, the needle orablation instrument (1112) may be used to perform the procedure forclosing the PFO as the scope (10110) is used to view or monitor theprocedure.

FIG. 105 illustrates one embodiment of a method for performing aorticvalve destenosis and/or decalcification using one or more balloons. Inone embodiment, two balloon structures may be deployed. A first balloon(10502) anchors the catheter structure (10510) in the aorta to the heart(10500). A lumen through the balloons is configured to allow for thepassage and flow of blood (10506). However, the flow is controlled by avalve (10508) within the second balloon structure (10504). When thestructures are anchored, blood flow (10506) through the first balloon isrestricted and controlled by the valve (10508) in the second balloonstructure (10504). A second catheter (not shown) may be advanced andnavigated to the first balloon (10502) and through an opening or port(10512) at the first balloon (10502) to dispense a bio-decalcifyingsolution or a mechanical instrument, e.g., scraper and vacuum tube,etc., for perform destenosis and/or decalcification procedures.

In addition to the operations and procedures as discussed, each of theabove discussed tools, systems, and/or assemblies may be utilized for,among other things, endolumenal urinary intervention, such as theexamination, removal, fragmentation, and/or destruction of stones suchas kidney or bladder stones

The prostate has a tendency to grow in aging males. In some cases, theprostate may grow to a sufficient size that would put pressure on theurethra and cause problems with urination, such as incomplete emptyingof the bladder or dribbling of urine. This condition is known as benignprostatic hyperplasia (BPH). There are a number of treatments for BPH. Atransurethral resection of the prostate (TURP) is one treatment that isusually performed to address BPH. TURP is a urological operation toremove some or all of an enlarged prostate gland so that urine can flowmore freely. This procedure is performed by observing the prostatethrough the urethra and removing tissue by electrocautery or sharpdissection. While the patient is under anesthesia, the surgeon inserts aresectoscope into the penis through the urethra. Some resectoscopes mayinclude a camera, light, valves for controlling irrigating fluid, and/orspecially adapted surgical instruments. These instruments allow thesurgeon to see the prostate clearly. A wire loop attachment that carriesan electric current is typically used to “chip away” at the prostate byremoving obstructing tissue and to seal blood vessels. During theoperation, the bladder is flushed with sterile solution to remove thechippings of prostate tissue. The debris is removed by irrigation andany remaining debris is eliminated in the urine over time. A catheterwith a large lumen may be inserted through the urethra to irrigate anddrain the bladder after the surgical procedure is completed.

Another procedure to treat the prostate may involve the use of a laser.Laser surgery uses a high-energy laser to destroy overgrown prostatetissue. The laser does not penetrate tissue deeply, so surroundingtissue is not harmed. There are a various types of laser surgeryavailable. Transurethral evaporation of the prostate (TUEP) is one type.This procedure is similar to TUVP. The difference is that prostatetissue is destroyed with laser energy instead of electrical current. Theprocedure is generally safe and causes limited bleeding. It is ofteneffective, with noticeable improvement in urine flow soon after theprocedure. Due to the evolution of laser technology, this procedure haslargely been replaced by new laser treatments such as PVP and HoLEP.Visual laser ablation of the prostate (VLAP) is another type of lasersurgery. This treatment involves applying sufficient laser energy to dryup and destroy excess prostate cells. Another type of surgery isphotosensitive vaporization of the prostate (PVP). PVP is newer form oflaser treatment for prostate gland enlargement. This procedure and itsresults are similar to transurethral resection of the prostate (TURP),which is the most common surgical treatment for enlarged prostate.However, PVP uses laser energy instead of the electrical current used byTURP to destroy prostate tissue. Holmium laser enucleation of theprostate (HoLEP) is yet another type of surgery. This is a newer laserprocedure used for men with urinary retention due to enlarged prostateand is similar to PVP.

FIG. 106 through FIG. 115 illustrate various apparatuses and methods forperforming prostate surgery. FIG. 106 illustrates a prostate (10604)with benign prostatic hyperplasia. As illustrated, the channel about thelateral lobe (10606) in the prostate gland (10604) through which thebladder (10602) empties out to the urethra (10608) is narrowed in theregion of the median lobe (10610). FIG. 107 illustrates a steerablesheath (422) and guide catheter (424) traveling up the urethra (10608).FIG. 108 illustrates a close-up view of the prostate gland (1604) andthe external urethral sphincter tissue (10612) near the prostate gland.In one embodiment, the steerable guide catheter (424) includes animaging fiber (10802) and laser (10804). As discussed above, the laser(10804) may be used to perform the various types of laser surgery foraddressing BPH. The imaging fiber (10802) may be a fiberscope, CCD chip,infrared imaging device, such as those available from CardioOpticsIncorporated, ultrasound device, or any other image capture device, forexample, to search for objects or to view tissue.

FIG. 109 illustrates another close-up view of the prostate gland (10604)with one embodiment of a catheter (424) that includes an imaging fiber(10802), laser (10804), and flush port (10902). In this embodiment, aflush port (10902) is also available in the catheter (424) for supplyingirrigating fluid and to flush the prostate (10604) during a lasersurgery procedure. FIG. 110 illustrates yet another close-up view of theprostate (10604) with another embodiment of a catheter (424) thatincludes an imaging fiber (10802), laser (10804), and flush port(11002). In this embodiment, the flush port (11002) points in anopposite from the imaging fiber (10802) and laser (10804). During aprocedure, the solution from the flush port can travel down the urethra(10608) to carry away prostate tissue chipped away by the laser (10804)while the imaging fiber (10802) provides a user, operator, or surgeon aview of the procedure from a viewpoint near the laser. FIG. 111illustrates an additional close-up view of the prostate (10604) with yetanother embodiment of a catheter (424) that includes an imaging fiber(10802), laser (10804), and flush port (10902). In this embodiment, theimaging fiber (10802) and flush port (10902) point downward towards theurethra (10608) and opposite to the laser (10804). The imaging fiber(10802) provides a user a better view of the laser (10804) in operationas the solution from the flush port flushes debris away from the imagingfiber (10802). FIG. 112 illustrates a further close-up view of theprostate (10604) with still another embodiment of a catheter (424) thatincludes an imaging fiber (10802), laser (10804), and flush port(10902). In this embodiment, the laser (10804) and flush port (10902)are directed downward toward the urethra, whereas the imaging fiber(10802) is directed upward towards the bladder (10602).

FIG. 113 illustrates a yet further close-up view of the prostate (10604)with one embodiment of a catheter (424) that includes a laser (10804)and grasper (11302). This embodiment includes a grasper (11302) to graspand remove any tissue samples as desired. FIG. 114 illustrates anotherclose-up view of the prostate (10604) with one embodiment of aresectoscope (11402) deployed within the working lumen of a steerableguide catheter (424). As discussed above, some embodiments of aresectoscope can also include an image capture device, flush ports, orother tools. Thus with an implementation as shown in FIG. 114, a TURPprocedure can be conducted. Tiny cutting blades deployed by theresectoscope (11402) can scrape away excess prostate tissue. FIG. 115illustrates yet another close-up view of the prostate (10804) with oneembodiment of a catheter (424) that includes a wire loop tool (11502),imaging fiber (10802), and flush port (10902). This wire loop tool(11502) may be configured such that it may be electrified to chip awayor remove and cauterize the excess tissue for treating BPH.

All of the aforementioned balloons, ablation tools, electrodes, etc.apparatuses are configured to be operatively coupled to the instrumentassembly (108) in combination with the sheath catheter (422) and guidecatheter (424). In some embodiments, the tools or instruments, e.g.,balloons, ablation tools, electrodes, etc., may be used with the guidecatheter (424) without the sheath catheter (422). In other embodiments,additional catheters may be used with the tools or instruments. Asapparent to one skilled in the art, the tools and instruments areconfigured to be either manually operated or robotically operated by theinstrument driver (106) in connection with the instrument (108). Some ofthe circuitry, electrical, and mechanical systems for controlling andoperating all of the aforementioned tools and instruments may beconfigured at the instrument driver (106) and the system electronicsrack (114).

FIG. 116 illustrates another embodiment of a robotic surgical system(100). As illustrated in FIG. 116, this embodiment of the roboticsurgical system (100) includes both a master input device (118) and apair of data gloves (11602) for providing input to the system (100). Thedata gloves (11602) may be connected to the operator control station(102) or the electronics rack (114) by a wire or wireless connection.This embodiment essentially provides two input system for one or moreoperators (116) to provide input to the system (100). For example, afirst operator or surgeon (116) may provide input to system (100) bymanipulating the master input device (118) and a second operator orsurgeon (116) may provide input to system (100) by the wireless dataglove (99) either near control station (102) or a some distance awayfrom both the operator control station (102) and the operation table(104).

Accordingly, the instrument driver (106) and instrument (108) may becontrolled by one or more operators via the manipulation of the masterinput device (118) or pair of data gloves (11602), or a combination ofboth the master input device (118) and the data gloves (11602). Forexample, the insertion and removal of an instrument (108) mounted on theinstrument driver (106) may be controlled via the data gloves (11602)and/or the master input device (118). Instrument (108) may includesteerable catheters (422, 424). In addition, tools or other types ofend-effectors may be mounted or inserted through the working lumens atthe end of the instrument assembly (108), such as the sheath (422) andguide (424). In some embodiments, the data gloves are configured to alsocontrol and manipulate these tools and end-effectors. In otherembodiments, the data gloves simply control the steering (pitch, yaw,rotation, etc) for the instrument assembly, e.g., sheath (422) and/orguide (424). In yet another embodiment, the data gloves (11602) maymaneuver an imaging fiber located at the tip of instrument (108) suchthat the field of view can be changed based on movements of a data glove

A data glove (11602) is generally defined as a glove equipped withsensors that sense the movements of the hand and interfaces thosemovements with a computer in the electronics rack (114). Data gloves mayinteractive devices that resemble gloves worn on the hands, which mayfacilitate tactile sensing and fine-motion control in robotics andvirtual reality. Data gloves are commonly used in virtual realityenvironments where the user sees an image of the data glove and canmanipulate the movements of the virtual environment using the glove.Data gloves are one of several types of electromechanical devices usedin haptics applications. Tactile sensing involves simulation of thesense of human touch and includes the ability to perceive pressure,linear force, torque, temperature, and surface texture. Fine-motioncontrol involves the use of sensors to detect the movements of theuser's hand and fingers, and the translation of these motions intosignals that can be used by a virtual hand (for example, in gaming) or arobotic hand (for example, in remote-control surgery). Sophisticateddata gloves also measure movement of the wrist and elbow. A data glovemay also contain control buttons or act as an output device, e.g.vibrating under control of the computer. The user usually sees a virtualimage of the data glove and can point or grip and push objects.

FIG. 117 illustrates one embodiment of the operator control station ofthe system (100). The operator control station (102) of this embodimentincludes three display monitors (122), a touch-screen user interface(11702), a control button console (11704), a master input device (118),and a pair of data gloves (11602). Master input device (118) andwireless data gloves (11602) serve as user interfaces through which theuser can control the operation of the instrument driver (106), theinstrument (108), and any additional attachments, tools, instruments,etc. As shown in FIG. 117, the master input device (118) is locatedabout the center of the operator control station (102) just under thecenter screen. The data gloves (11602) are coupled to the controlstation (102) via a cable or wireless connection. Wireless data glovesenables a user or surgeon to provide command or operate the system (100)substantially untethered remotely from the operator station (102). Alsodepicted is a device disabling switch (11706) configured to disableactivity of the instrument temporarily. As illustrated in FIG. 118, theelectronics rack (114) may be support by a cart or configured withwheels for easy movability within the operating room or catheter lab,one advantage of which is location of the operator control station (102)which may be moved away from the operation table (104) and radiationsources, thereby substantially decrease or eliminate the potential forexposure to radiation or reduce the radiation dosage to the operator.

Referring to FIG. 119, one embodiment of an operator control station(102) is depicted showing a control button console (11704), which mayinclude a computer, a computer control interface device, such as amouse, a visual display system (122), a master input device (118), and apair of data gloves (11602). In addition to buttons on the buttonconsole (11704), footswitches and other known types of user controlinterfaces may be utilized to provide an operator interface with thesystem controls.

Still referring to FIG. 119, the master input device (118) of thisembodiment may be a multi-degree-of-freedom device having multiplejoints and associated encoders. An operator interface (11902) may beconfigured for comfortable interface with the hand or fingers or theoperator 116. The depicted embodiment of the operator interface (11902)is substantially spherical. Further, the master input device may haveintegrated haptics capability for providing tactile feedback to theuser. Also illustrated in FIG. 119 is a pair of data gloves (11602)coupled to the operator control station. In this embodiment, a singleuser can utilize the master input device (11902) or the pair of datagloves (11602), or even a combination of both, to control the instrumentdriver (106) and one or more instruments (108). However, it is alsopossible for two users to take turns controlling the instrument driver(106) and associated instruments (108). For instance, one person may beseated at the control station in position to manipulate the master inputdevice (118) while a second person may be wearing the data gloves. Bygating or multiplexing which master device is active at a given time,the two people can switch off running or operating the system (100). Onescenario where this may be useful is where a resident is working at thecontrol station and a chief surgeon wearing the data gloves is ready tostep in as needed. Even though the examples illustrated with thesefigures show data gloves in close proximity to the control station, theoperating distance of the gloves may vary depending on theimplementation. For example, the gloves can be configured to operateaway from the control station or a remote location, such as a differentroom from which the current procedure is happening. Thus, the operatingrange may be limited by the physical length of a cable connection, ifany, or by the wireless connectivity.

FIG. 120 illustrates one embodiment of a robotic catheter system (100)that includes data gloves (11602). In this embodiment, the user (116) isseated at a station without a master input device and input is providedthrough the data gloves (11602). FIG. 121 illustrates the operatorcontrol station (102) of FIG. 120. As shown in this example, the datagloves (11602) are connected to the console with cables. Note that thissystem (100) also has the data gloves (11602) in lieu of a master inputdevice (118). FIG. 122 illustrates another embodiment of an operatorcontrol station (102) including a pair of wireless data gloves (11602)wherein the user (116) can remotely operate the station (102) andinstrument driver (106) away from the station (102). FIG. 123 illustratethe input devices of the control station (102) of FIG. 122 with awireless data glove (11602) resting on the table top.

The data gloves (11602) of implementation for part of a hand data motioncapturing solution for the receiving user input. In one embodiment, thedata gloves (11602) can measure finger flexure as well as the abductionbetween the fingers. Finger flexure is measured at two places on thefinger: at the first finger joint (knuckle) and at the second fingerjoint. Abduction sensors can be located between fingers. In anotherembodiment, the data gloves (11602) measure finger flexure, but notabduction. In this instance, each sensor measures finger flexure as anaverage of knuckle and the first joint. A plurality of sensitive datasensors is mounted on the gloves to accurately sense/detect usermovements and communicate data signals to system software and hardware.Although one embodiment employs data gloves having five or fourteen datasensors, different numbers of data sensors can be used depending on theresolution desired. One embodiment of the data gloves (11602) featuresan auto calibration function, 8-bit flexure and abduction resolution,and low drift. Greater resolution can be achieved in sensed movements byincreasing the number of data bits in the sensor resolution andincreasing the sampling rate. In one embodiment, the glove data can alsobe captured and recorded at the system for later evaluation. In anotherembodiment, multiple gloves can be supported simultaneously. Similarly,a single data glove can be employed with other embodiments.

The data gloves (11602) may be a preferable user input device in someinstances because this solution can offer comfort, ease of use, and asmall form factor, especially when compared to other types of inputdevices. In one implementation, the data gloves (11602) are constructedwith stretch Lycra® fiber (as marketed by INVISTA of Wichita, Kans.),but other types of material such as cotton and nylon are also suitable.Although different sizes of data gloves can be manufactured andutilized, one implementation makes use of a one size fits all designwherein the glove can stretch to fit different users without comprisingthe integrity or sensitivity of the data gloves. Furthermore, variousphysical aspects of the data glove can differ based upon the design. Forinstance, some gloves may be manufactured without finger tips. Othergloves may extend beyond a user's wrist. Another glove may includecontrol buttons or switches.

For the embodiments described in these examples, the pair of data gloves(11602) includes a left hand glove and a right hand glove. In someembodiments, a single data glove may be used, instead of two gloves.Depending on the system architecture and the user software, the datagloves (11602) can be used for a variety of functions. Note that thedata gloves are not limited to controlling the instrument driver (106)and associated instruments (108). For example, one embodiment of systemmay employ the data gloves in combination with a head mounted display.In essence, the user may be given the experience of working within avirtual environment. Thus a user wearing the combination of the headmounted display can visualize operating conditions and scenery at distalend of an catheter and to manipulate a tool or tissue at the distal endof the catheter with the data gloves. In one implementation, the datagloves are capable of providing tactile feedback to the user in responseto contact at the distal tip of the catheter. In yet another embodiment,the display from the screens (122) and a set of virtual controls may beprojected into the head mounted display. By using the data gloves(11602), a user may be able to operate various virtual system controlswithin the virtual environment in addition to controlling the instrumentdriver and catheters. In some aspects, the data gloves may serve as amore instinctive or intuitive type of control as a user may be morecomfortable with the concept of virtually grasping or manipulatingobjects by simple hand motions and having an item being virtuallycontrolled respond as if the user was physically touching the item.

The data gloves (11602) can employ a high speed connectivity interfaceto communicate with the control system. In one embodiment, the signalsare transmitted from the data gloves (11602) to the system via aphysical cable such as an RS-232 cable, USB cable, or serial data cable,but are not limited to these examples. For one embodiment, the datagloves are designed without any magnetic parts so that the data glovescan be safely used in a magnetic resonance imaging (MRI) environment. Inthis case, the sensed data is communicated to the system by way of anoptical fiber. In another embodiment, the data signals are transmittedfrom the data gloves (11602) to the system wireless via radio waves orinfrared transmissions through protocols such as, but not limited to,Bluetooth, WiFi, ZigBee, IEEE 802.11, IrDa, 3G, and RFID. Depending onthe particular implementation, the sensors may be powered by the systemvia the cable connection. In a wireless embodiment, the sensors may bepowered by a rechargeable or disposable battery pack coupled to thegloves. Data gloves, such as the data gloves in the 5DT Data Glove Ultraseries or the 5DT Data Glove MRI series, are available frommanufacturers such as 5DT (Fifth Dimension Technologies), Inc. ofIrvine, Calif. Additional data gloves include the ShapeHand™ availablefrom Measurand Inc. of Fredericton, NB, Canada and the CyberGlove® IIWireless Data Glove available from Immersion Corporation of San Jose,Calif.

Similarly, master input devices are available from manufacturers such asSensAble Technologies, Inc. of Woburn, Mass. under the trade namePhantom® Haptic Devices or from Force Dimension of Lausanne, Switzerlandunder the trade name Omega Haptic Device. In one embodiment featuring anOmega-type master input device, the motors of the master input deviceare utilized for gravity compensation. In other words, when the operatorreleases the master input device from his hands, the master input deviceis configured to stay in position, or hover around the point at which iswas left, or another predetermined point, without gravity taking thehandle of the master input device to the portion of the master inputdevice's range of motion closest to the center of the earth. In anotherembodiment, haptic feedback is utilized to provide feedback to theoperator that he has reached the limits of the pertinent instrumentworkspace. In another embodiment, haptic feedback is utilized to providefeedback to the operator that he has reached the limits of the subjecttissue workspace when such workspace has been registered to theworkspace of the instrument (i.e., should the operator be navigating atool such as an ablation tip with a guide instrument through a 3-D modelof a heart imported, for example, from CT data of an actual heart, themaster input device is configured to provide haptic feedback to theoperator that he has reached a wall or other structure of the heart asper the data of the 3-D model, and therefore help prevent the operatorfrom driving the tool through such wall or structure without at leastfeeling the wall or structure through the master input device). Inanother embodiment, contact sensing technologies configured to detectcontact between an instrument and tissue may be utilized in conjunctionwith the haptic capability of the master input device to signal theoperator that the instrument is indeed in contact with tissue.

FIG. 124 illustrates one embodiment of the data glove (12402). In thisimplementation, one sensor (12404) is located on each finger. In analternative embodiment, two sensors are located on each finger, inaddition to a sensor at the abduction between each finger. FIG. 125illustrates one embodiment of a wired data glove (12502). In thisexample, the data glove (12502) is physically connected to the system(100) and communicates via the cable (12504). FIG. 126 illustrates oneembodiment of a wireless data glove arrangement. In this embodiment, thedata gloves (12602) are coupled to a wireless transmitting unit (12604).Wireless transmitting unit (12604) transmits data wirelessly from thegloves (12602) via radio or infrared transmissions or other suitableform of wireless transmission to the system (100). FIG. 127 illustratesa display screen showing the sensor data signals received by the system(100) from the data gloves in accordance to one embodiment.

Referring to FIG. 128, an overview of an embodiment of a controls systemflow diagram is depicted. As illustrated, a master computer (12800) runsmaster input device software (12804), data glove software (12802),visualization software, instrument localization software, and softwareto interface with operator control station buttons and/or switches. Inthis embodiment, a data glove input device (11602) and a master inputdevice (118) are coupled to the master computer (12800). The mastercomputer (12800) processes the commands and forwards instructions to thecontrol and instrument driver computer, which maneuvers the instrumentdriver and mounted instruments in response.

In one embodiment, the master input device software is a proprietarymodule packaged with an off-the-shelf master input device system, suchas the Phantom® from SensAble Technologies, Inc., which is configured tocommunicate with the Phantom® Haptic Device hardware at a relativelyhigh frequency as prescribed by the manufacturer. Other suitable masterinput devices are available from suppliers such as Force Dimension ofLausanne, Switzerland. The master input device (118) may also havehaptics capability to facilitate feedback to the operator, and thesoftware modules pertinent to such functionality may also be operated onthe master computer (12800). In one embodiment, the data glove softwareis a device driver or software model, such as a driver for the 5DT DataGlove. In other embodiments, software support for the data glove masterinput device is provided through application drivers such as KaydaraMOCAP, Discreet 3D Studio Max, Alias Maya, and SoftImage|XSI.

While multiple embodiments and variations of the many aspects of theinvention have been disclosed and described herein, such disclosure isprovided for purposes of illustration only. Many combinations andpermutations of the disclosed system, apparatus, and methods are usefulin minimally invasive medical diagnosis and intervention, and theinvention is configured to be flexible and adaptable. The foregoingillustrated and described embodiments of the invention are suitable forvarious modifications and alternative forms, and it should be understoodthat the invention generally, as well as the specific embodimentsdescribed herein, are not limited to the particular forms or methodsdisclosed, but also cover all modifications, alternatives, andequivalents as defined by the scope of the appended claims. Further, thevarious features and aspects of the illustrated embodiments may beincorporated into other embodiments, even if not so described herein, aswill be apparent to those skilled in the art. In addition, although thedescription describes data being mapped to a three dimensional model,data may be mapped to any mapping or coordinate system, including twodimensional, static or dynamic time-varying map, coordinate system,model, image, etc. All directional references (e.g., upper, lower,upward, downward, left, right, leftward, rightward, top, bottom, above,below, vertical, horizontal, clockwise, counterclockwise, etc.) are onlyused for identification purposes to aid the reader's understanding ofthe invention without introducing limitations as to the position,orientation, or applications of the invention. Joining references (e.g.,attached, coupled, connected, and the like) are to be construed broadlyand may include intermediate members between a connection of elements(e.g., physically, electrically, optically as by an optically fiber,and/or wirelessly connected) and relative physical movements, electricalsignals, optical signals, and/or wireless signals transmitted betweenelements. Accordingly, joining references do not necessarily infer thattwo elements are directly connected in fixed relation to each other. Itis intended that all matters contained in the description or shown inthe accompanying drawings shall be interpreted as illustrative only andnot limiting. Modifications, alternatives, and equivalents in thedetails, structures, or methodologies may be made without departing fromthe spirit and scope of the invention as defined by the appended claims.

What we claim is:
 1. A robotic medical system configured for performinga medical procedure on an abnormality of a prostate of a patient, thesystem comprising: a controller including a master input device; aninstrument driver in communication with the controller; an elongateflexible instrument operatively coupled to the instrument driver,whereby a distal end portion of the catheter instrument may berobotically manipulated by a remotely located system operator bycorresponding manipulation of the master input device; a surgical tooloperatively coupled to the controller and carried on the distal endportion of the flexible instrument, and an imaging system operativelycoupled to the controller and configured to acquire and display an areaof a patient's prostate containing the abnormality, wherein thecontroller and master input device are configured to allow a systemoperator to advance the distal portion of the flexible instrument alongthe patient's urethra and operate the surgical tool by manipulation ofthe master input device in order to perform a medical procedure anabnormality of the patient's prostate, wherein the operation of thesurgical tool is at least partially automatically controlled based onthe image obtained by the imaging system.
 2. The system of claim 1,wherein the surgical tool is a laser, and the abnormality is treated byconveying laser energy from the laser to destroy tissue of the prostate.3. The system of claim 1, wherein the surgical tool is a resectoscope,and the abnormality is treated by scraping tissue away from the prostatewith the resectoscope.
 4. The system of claim 1, wherein the surgicaltool is a wire loop tool, and the abnormality is treated by conveyingelectrical energy from the wire loop tool.
 5. The system of claim 1,wherein the surgical instrument is a tissue grasper that is operated toremove tissue from the prostate.
 6. The system of claim 1, wherein theimaging system comprises an imaging device carried on the distal endportion of the flexible instrument.
 7. The system of claim 6, whereinthe imaging device is an optical imaging fiber.
 8. The system of claim1, further comprising a flush port disposed on the distal end portion ofthe flexible instrument.
 9. A robotic medical system configured forperforming a medical procedure on an abnormality of a prostate of apatient, the system comprising: a controller including a master inputdevice; an instrument driver in communication with the controller; anelongate flexible instrument operatively coupled to the instrumentdriver, whereby a distal end portion of the catheter instrument may berobotically manipulated by a remotely located system operator bycorresponding manipulation of the master input device; a surgical tooloperatively coupled to the controller and carried on the distal endportion of the flexible instrument, and an imaging system operativelycoupled to the controller and configured to acquire and display an areaof a patient's prostate containing the abnormality, wherein thecontroller and master input device are configured to allow a systemoperator to (i) create a restricted zone, based on the displayed imageof the area of the prostate, into which the surgical tool is restrictedfrom entering by a navigation logic of the robotically controlledsystem, and (ii) cause the instrument driver to manipulate the distalend portion of the flexible instrument so that the surgical tool ispositioned proximate the prostate abnormality without entering therestricted zone, and wherein the operation of the surgical tool is atleast partially automatically controlled based on the image obtained bythe imaging system.
 10. The system of claim 9, wherein the controllerand master input device are further configured to allow a systemoperator to locate an anatomical landmark using the displayed image ofthe area of the patient's prostate, and store a desired position andorientation of the distal end portion of the guide instrument proximatethe anatomical landmark.
 11. The system of claim 9, wherein thecontroller and master input device are further configured to allow asystem operator to advance the distal portion of the flexible instrumentalong the patient's urethra, and to operate the surgical tool bymanipulation of the master input device.
 12. The system of claim 9,wherein the surgical tool is a laser, and the abnormality is treated byconveying laser energy from the laser to destroy tissue of the prostate.13. The system of claim 9, wherein the surgical tool is a resectoscope,and the abnormality is treated by scraping tissue away from the prostatewith the resectoscope.
 14. The system of claim 9, wherein the surgicaltool is a wire loop tool, and the abnormality is treated by conveyingelectrical energy from the wire loop tool.
 15. The system of claim 9,wherein the surgical instrument is a tissue grasper that is operated toremove tissue from the prostate.
 16. The system of claim 9, wherein theimaging system comprises an imaging device carried on the distal endportion of the flexible instrument.
 17. The system of claim 16, whereinthe imaging device is an optical imaging fiber.
 18. The system of claim1, further comprising a flush port disposed on the distal end portion ofthe flexible instrument.